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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 W62016344
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Erosion (1750); Conjunctivitis (1784); Corneal Abrasion (1789); Corneal Edema (1791); Corneal Scar (1793); Corneal Ulcer (1796); Hypopyon (1913); Keratitis (1944); Neovascularization (1978); Pain (1994); Red Eye(s) (2038); Scar Tissue (2060); Swelling (2091); Blurred Vision (2137); Loss of Vision (2139); Corneal Infiltrates (2231); Discomfort (2330)
Event Date 08/16/2017
Event Type  Injury  
Manufacturer Narrative
Complaint sample was not returned for evaluation. A review of the lot device history records is ongoing. Based on available information, no causal factors can be determined and no conclusion can be drawn.
 
Event Description
A consumer reported that he is "suffering from a chronic infection in the left eye due to poor quality lenses. " communications with the consumer indicated the consumer first used 3 lenses comfortably but felt discomfort while using the 4th pair of lenses, theses lenses were discarded. The consumer wore a fresh pair of lenses and reported the problem still persisted. After which the consumer discontinued the lenses and contacted an ophthalmologist. A report from the practitioner indicates the consumer presented with symptoms of pain, blurring and redness in the left eye. The practitioner observed; bulbar injection, conjunctivitis, external lid/lashes abnormalities (edema) and hypopyon of the left eye. In addition, the practitioner observed corneal edema, staining and infiltrates in the central 4 mm x 4 mm of the cornea, a corneal abrasion/erosion, specified as central sloughing, the corneal abrasion/erosion penetrated bowman¿s membrane, left a residual scar, and it is located in the central 6 mm of the cornea. The practitioner also indicated, the patient had an infectious corneal ulcer in the central 4 mm x 4 mm ring infiltrate, has microbial keratitis and neovascularization and the new blood vessels extend into the central 6 mm of the cornea. The practitioner indicated there is a new corneal scar in the central 4 mm and that the patient has permanent loss of vision. Cultures were taken and the results were positive for pseudomonas aeruginosa. The practitioner's diagnosis was left eye infectious keratitis with hypopyon. Patient was provided fortified vancomycin and fortified ceftazidime. The patient was instructed to stay at the hospital for 5 days while receiving this treatment and to temporary suspend contact lens wear. Other treatment provided was reported as use of cycloplegics. In the practitioner¿s opinion, the likely cause of the event was contact lens induced keratitis. The practitioner indicated the event was not life threatening; however, it did result in permanent impairment, and the event did need medical or surgical intervention to preclude permanent impairment of a body function/structure. Information related to the patient¿s lens care practices were not available. The patient is continuing to receive treatment.
 
Manufacturer Narrative
Additional information: a review of the lot device history records concludes that the product was manufactured, packaged, and released according to global and plant product specifications. Based on available information, no causal factors can be determined and no conclusion can be drawn.
 
Event Description
Received additional information from the consumer that they were hospitalized for 10 days instead of the originally reported 5 days. Received confirmation from the consumer's' doctor that their current vision is 6/24 with no inflammation present. Their vision prior to the event is unknown. They are currently still under treatment and make weekly trips to the doctor to follow up.
 
Event Description
Received additional information from the treating physician that the scar is located in the para central of the cornea and not in the center of the cornea as previously reported by the physician. The consumer has also indicated they will follow up with another specialist for his persisting symptoms. Additional medical information regarding the event has been requested from the new doctor. This information has not been received.
 
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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
Manufacturer (Section G)
BAUSCH + LOMB
unit 424/425, cork road
industrial estate
waterford
EI
Manufacturer Contact
tes proud
1400 north goodman street
rochester, NY 14609
5853388549
MDR Report Key6883232
MDR Text Key87182688
Report Number0001313525-2017-02784
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K994125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Patient
Type of Report Initial,Followup,Followup,Followup
Report Date 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Lot NumberW62016344
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/21/2017 Patient Sequence Number: 1
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