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

Lot Number 222

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Eye Infections (4466); Eye Pain (4467)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

Product was requested, however the consumer decided against returning the product for evaluation.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A consumer reported experiencing red eye and irritation in their right eye 2 hours after inserting a new contact lens.The consumer removed the lens and discontinued use.The next day they woke up with pain in the back of their eye and they sought medical attention.They were diagnosed with a corneal ulcer and a scraping was performed.The consumer was prescribed gentamicin sulfate 0.5%, 1 drop every 5 hours for 6 months and zymar two drops every 30 minutes alternately with gentamicin sulfate 1.4% two drops every 30 minutes.The consumer returned about two weeks later and was prescribed gentamicin sulfate 1.4% 4 hours for 6 months and to discontinue zymar.Follow up with medical records indicate that the cultures showed pseudomonas aeruginosa with pain and blurred vision improving with continued light sensitivity.The consumer confirmed that there was a 2.5x2mm corneal ulcer in the right eye, central without hypopyon and conjunctival hyperemia.The corneal ulcer was confirmed to be healed without infiltrates.Additional information has been requested but not received.

Manufacturer Narrative

A full comprehensive review has been carried out.This review confirmed that there were no materials out of specification used to produce this lot.No anomalies during curing or sterilization and no process anomalies observed.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Patient indicated they have resumed contact lens wear at an increased prescription.

Manufacturer Narrative

Based on all information, no causal factors can be determined and no conclusion can be drawn.

• 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 NY 14609 ; EI 14609
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 14169849
• MDR Text Key: 289770297
• Report Number: 0001313525-2022-00047
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K994125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 73 KG