SOFLENS DAILY DISPOSABLE CONTACT LENS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-11-29 for SOFLENS DAILY DISPOSABLE CONTACT LENS manufactured by Bausch & Lomb Incorporated.

Event Text Entries

[128792454] A lot number has been requested but not provided, the lens has been discarded by the patient. Additional medical information was requested, however has not been received. This report is for the left eye, -3. 75 power. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10


[128792455] A consumer reported that on (b)(6) the consumer inserted a new pair of lenses and experienced no eye discomfort while wearing the lenses. Upon removal of the lenses the consumer experienced stinging in their right eye. At this time they only removed half of a lens from the right eye and had continued eye pain. On the next day the consumer visited a hospital with complaints of eye pain in both eyes. The doctor removed half of a contact lens in the consumer? S right eye and diagnosed them with bilateral conjunctivitis. They were prescribed an eye drop; however they do not recall the name of this eye drop. The consumer experienced aggravated eye pain in both eyes and returned to the hospital on (b)(6). The doctor removed another piece of contact lens; it is unclear which eye the lens was removed from. They were prescribed levofloxacin eye drops and clopidine eye drops at one drop 3 times daily for both eyes until (b)(6). On (b)(6) the consumer continued to have eye pain and visited the emergency room. They were diagnosed with conjunctivitis of both eyes again. They returned to the hospital on (b)(6) and were prescribed sodium hyaluronate eye drops to use daily. On the (b)(6) the consumer visited the hospital again due to continued pain. They were diagnosed with corneal exfoliation of the upper eyelid on the right eye and bilateral conjunctivitis. They were prescribed fluorometholone eye drops, one drop 3 times a day both eyes and ganciclovir eye gel at night. On the (b)(6) the consumer right eye recovered, however they continued to have left eye pain. They visited the hospital on (b)(6) and they were prescribed fluorometholone eye drops and ganciclovir eye gel. They reported they would return to the hospital for a checkup. Medical records and doctors contact information has been requested, but not received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001313525-2018-00220
MDR Report Key8116697
Report SourceCONSUMER,FOREIGN
Date Received2018-11-29
Date of Report2018-11-01
Date of Event2018-09-28
Date Added to Maude2018-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JENNIFER GAMET
Manufacturer Street1400 NORTH GOODMAN STREET
Manufacturer CityROCHESTER NY 14609
Manufacturer CountryUS
Manufacturer Postal14609
Manufacturer Phone5853386853
Manufacturer G1BAUSCH + LOMB
Manufacturer StreetUNIT 424/425, CORK ROAD INDUSTRIAL ESTATE
Manufacturer CityWATERFORD
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOFLENS DAILY DISPOSABLE CONTACT LENS
Generic NameLENS, CONTACT, DISPOSABLE
Product CodeMVN
Date Received2018-11-29
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH & LOMB INCORPORATED
Manufacturer Address1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-29

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