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

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 discarded.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 4mm x4mm 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 6mm of the cornea.The practitioner also indicated, the patient had an infectious corneal ulcer in the central 4mm x 4mm 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 4mm 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 cefitazidime.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.

• Brand Name: SOFLENS 59 (HILAFILCON B) CONTACT LENS
• Type of Device: LENSES, 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 Key: 6883259
• MDR Text Key: 87188428
• Report Number: 0001313525-2017-02785
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K994125
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Lot Number: W62016344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 10/04/2017; 11/17/2017; 11/17/2017
• Supplement Dates FDA Received: 11/01/2017; 12/13/2017; 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 26 YR