MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Insufficient Information (3190)

Patient Problems Corneal Scar (1793); Foreign Body Sensation in Eye (1869); Headache (1880); Unspecified Infection (1930); Keratitis (1944); Pain (1994); Burning Sensation (2146)

Event Date 11/01/2005

Event Type  Injury  

Manufacturer Narrative

Product and lot number were not available.Follow up with the treating doctor indicated they have no record of the consumer using the product.Renu with moistureloc multi-purpose solution was recalled from the global market on may 15, 2006.At that same time, the company discontinued the worldwide sales and distribution of the device.Also, the premarket notifications (k033854 and k051755) for the device were withdrawn by bausch + lomb.

Event Description

A consumer reported about fifteen years ago, after using the product, they experienced burning eyes, headaches, light sensitivity and they could barely open their eyes.They visited their eye doctor and was diagnosed with bilateral eye infection and retina scarring in their left eye.They reported after being prescribed an unknown antibiotic and lasik surgery, they have almost fully recovered as the scarring is healing.Follow up with the treating doctor indicates they have no record of the patient using the complaint product.They visited the office with left eye pain, stinging, foreign body sensation and light sensitivity.Their eyesight remained 20/20 with contact lenses.They were diagnosed with left eye focal keratitis, superficial punctate keratopathy and left faint central corneal scar.They were treated with acular ls.The doctor indicates they do not wish to provide additional medical information.

• Brand Name: RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
• 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: 9721556
• MDR Text Key: 183916240
• Report Number: 0001313525-2020-00035
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,01/21/2020

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/18/2020
• 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
• Removal/Correction Number: Z-1201-06
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention