MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BOSTON ADVANCE CLEANER; ACCESSORIES, SOFT LENS PRODUCTS

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

Patient Problem Acanthameba Keratitis (1945)

Event Type  Injury  

Manufacturer Narrative

The consumer indicated that the instructions for use for the cleaner indicate that tap water can be used to rinse the lenses.Instructions for use for the cleaner indicate that the contact lenses should be soaked in the conditioning solution after cleaning.The conditioning solution is for wetting, disinfecting, and soaking the lenses after cleaning.The complaint product was not returned for evaluation and product lot information was not provided.Additional information regarding the consumer's experience has been requested but has not been received.

Event Description

A consumer reported via one of the manufacturer¿s social media pages that after using the contact lens cleaner and rinsing her lenses with tap water she developed acanthamoeba keratitis of the left eye.Consumer reported that she is out of work as a result of this experience and that she is using three unspecified eye drops for treatment.She reported that she may lose sight in her left eye.In addition to rinsing her contact lenses with tap water, the consumer also indicated that she showered with her contact lenses and swam with her contact lenses.Additional information regarding the consumer's experience has been requested but has not been received.

• Brand Name: BOSTON ADVANCE CLEANER
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 8507 pelham road; greenville SC 29615
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 8077228
• MDR Text Key: 127342025
• Report Number: 0001313525-2018-00211
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K974466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other