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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED SOFLENS 59 (HILAFILCON B) CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR

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BAUSCH & LOMB INCORPORATED SOFLENS 59 (HILAFILCON B) CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number W72052646
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Scar (1793); Hypopyon (1913); Irritation (1941); Acanthameba Keratitis (1945); Pain (1994); Red Eye(s) (2038); Loss of Vision (2139); Excessive Tear Production (2235)
Event Date 09/20/2018
Event Type  Injury  
Manufacturer Narrative
The complaint lens has been requested, but the consumer does not wish to return it. A review of the lot device history records is in progress. Based on available information, no causal factors can be determined and no conclusion can be drawn.
 
Event Description
The consumer reported that for the past two months the consumer has been suffering from acanthamoeba keratitis. They stated upon removal of the lens they had right eye irritation and watering. They reported visiting the hospital the same day. The consumer reports they had to sit in a dark room for two months without exposure to light. They still are experiencing some light sensitivity and difficulty viewing digital screens. The consumer reported mental trauma, loss of confidence, and reported their ¿mental strength is gone¿. The consumer states they have permanent loss of vision as a result of this diagnosis. The consumer provided a letter from the doctor which confirmed that the patient visited the doctor on (b)(6) 2018 with symptoms of redness, ocular pain, watering, and a ¿pricking sensation¿ in their right eye after removal of the contact lens for the past three days. This is inconsistent with the consumer¿s report of immediately following up after experiencing the symptoms the first day. An examination of the anterior segment of the eye showed 2mmx2mm epithelial defect with stromal edema, 3. 5mmx4mm ring infiltrate, thinning and hypopyon in the right eye. Corneal scraping was performed with confirmed acanthamoeba on the right eye. The patient was prescribed a tablet albendazole 400 mg 2 times a day, vigamox 8 times a day and phmb hours, refresh tears 6 times a day and homide 2 time a day in the right eye. The patient followed up regularly with uneventful checkups. On (b)(6) the patient had 6/12p visual acuity in the right eye. A corneal scar was confirmed. The consumer was prescribed tab doxy 100 mg 2 times a day, phmd 4 times a day, lowdex 2 times a day and genteal 6 times a day in the right eye. Several attempts have been made to obtain the consumer's consent to contact the treating doctor. They have sought legal council and wants further communication to be with the lawyer present. At this time they are not willing to cooperate.
 
Manufacturer Narrative
Concomitant product information was provided. Attempts to obtain additional event information have been unsuccessful. The review of the manufacturing records concludes that the product was manufactured, packaged and released according to global and plant product specifications. No anomalies were found. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
 
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Brand NameSOFLENS 59 (HILAFILCON B) CONTACT LENS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
1400 north goodman street
rochester NY 14609
MDR Report Key8190236
MDR Text Key131181071
Report Number0001313525-2018-00246
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
PMA/PMN Number
K994125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberW72052646
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
Treatment
RENU MULTIPLUS MULTI-PURPOSE
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