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Review Systane Safety Reports submitted to FDA

Total Systane reports: 12.
Systane FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 1.
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FDA Reported Systane Side Effects: ulcerative keratitis, eye pain, keratitis bacterial, eye infection fungal, ocular hyperaemia, intraocular pressure increased, eye infection, corneal scar, photophobia, eye irritation, nervous system disorder.
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Systane Side Effects Report #5671120-9
Consumer or non-health professional from UNITED STATES reported SYSTANE problem on Feb 27, 2008. Female patient was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: corneal disorder, erythema, erythema of eyelid, eye burns, eyelid disorder. SYSTANE dosage: unknown. Patient recovered.

Systane Side Effects Report #5675980-7
SYSTANE problem was reported by a Health Professional from UNITED STATES on Feb 29, 2008. Female patient, weighting 140.0 lb, was diagnosed with dry eye and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: corneal dystrophy, eye disorder, eyelid disorder, eyelid oedema, visual acuity reduced. SYSTANE dosage: unknown. During the same period patient was treated with SYSTANE EYE DROPS, SYSTANE EYE DROPS, TIMOLOL MALEATE, LEVOTHYROXINE, EVISTA, ZOLPIDEM, ISOSORBIDE DINITRATE, ASPIRIN. Patient recovered.

Systane Side Effects Report #5619802-9
Health Professional from UNITED STATES reported SYSTANE problem on Jan 23, 2008. Female patient, 32 years of age, weighting 138.0 lb, was diagnosed with corneal abrasion, dry eye and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: conjunctival hyperaemia, conjunctival oedema, corneal erosion, eye burns, eye irritation, eye pain, lacrimation increased, no therapeutic response. SYSTANE dosage: unknown. During the same period patient was treated with SYSTANE EYE DROPS. Patient recovered.

Systane Side Effects Report #5639604-7
SYSTANE problem was reported by a Health Professional from UNITED STATES on Feb 06, 2008. Female patient, 71 years of age, was diagnosed with dry eye and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: cellulitis orbital, dacryocanaliculitis, eye abscess, eye infection, stenotrophomonas infection, therapeutic product contamination. SYSTANE dosage: unknown. Patient was hospitalized. Patient died on 01/01/2007.

Systane Side Effects Report #5527629-1
Consumer or non-health professional from UNITED STATES reported SYSTANE problem on Nov 26, 2007. Female patient, 71 years of age, was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: cellulitis, eye infection, stenotrophomonas infection, therapeutic product contamination. SYSTANE dosage: unknown. Patient recovered.

Systane Side Effects Report #5533975-8
SYSTANE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 16, 2007. Male patient was diagnosed with dry eye and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: burning sensation, eye irritation, visual acuity reduced. SYSTANE dosage: unknown. Patient recovered.

Systane Side Effects Report #5472265-9
Consumer or non-health professional from UNITED STATES reported SYSTANE problem on Sept 10, 2007. Female patient, 68 years of age, weighting 133.0 lb, was diagnosed with dry eye and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: corneal scar, eye infection, intraocular pressure increased, ulcerative keratitis. SYSTANE dosage: unknown. During the same period patient was treated with NORVASC, PLAVIX, LEVOXYL, METOPROLOL TARTRATE, FISH OIL. Patient recovered.

Systane Side Effects Report #5407131-8
SYSTANE problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 03, 2007. Female patient, 61 years of age, weighting 117.0 lb, was diagnosed with dry eye and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: eye infection, eye pain. SYSTANE dosage: unknown. Patient recovered.

Systane Side Effects Report #5409805-1
Physician from UNITED STATES reported SYSTANE problem on Feb 27, 2007. Male patient, 52 years of age, weighting 180.0 lb, was diagnosed with dry eye and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: cellulitis, eye infection fungal, eyelid infection. SYSTANE dosage: unknown. During the same period patient was treated with CRESTOR, HYDROCHLOROTHIAZIDE, ASPIRIN. Patient recovered.

Systane Side Effects Report #5441852-6
SYSTANE problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 17, 2007. Female patient was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: eye irritation, eye pain, ocular hyperaemia, photopsia, retinal detachment, vitreous floaters. SYSTANE dosage: unknown. Patient recovered.

Systane Side Effects Report #5402364-9
Consumer or non-health professional from UNITED STATES reported SYSTANE problem on July 30, 2007. Male patient, child 11 years of age, weighting 75.00 lb, was diagnosed with dry eye, chemical eye injury and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: corneal abrasion, discomfort, erythema of eyelid, foreign body in eye, ocular hyperaemia. SYSTANE dosage: unknown. During the same period patient was treated with PATANOL. Patient recovered.

Systane Side Effects Report #5402364-9
SYSTANE problem was reported by a Consumer or non-health professional from UNITED STATES on July 30, 2007. Male patient, child 11 years of age, weighting 75.00 lb, was diagnosed with dry eye, chemical eye injury and was treated with SYSTANE. After drug was administered, patient experienced the following problems/side effects: corneal abrasion, discomfort, erythema of eyelid, foreign body in eye, ocular hyperaemia. SYSTANE dosage: unknown. During the same period patient was treated with PATANOL. Patient recovered.


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