BAUSCH AND LOMB ADVANCED EYE RELIEF EYE WASH EYE IRRIGATING SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for BAUSCH AND LOMB ADVANCED EYE RELIEF EYE WASH EYE IRRIGATING SOLUTION manufactured by Bausch And Lomb, Inc..

Event Text Entries

[122195375] Pt came in for a f/u appt on (b)(6) 2018. Pt strong contact lenses in clinic eye wash solution (bausch+lomb advanced eye relief eye wash eye irrigating solution lot #gh17017 6319814 with exp 08/2019). Ingredients listed as: 99. 05% purified water, boric acid, sodium borate and sodium chloride, and benzalkonium chloride 0. 01%. The pt put on her contact lenses after storing them in this solution and left the hospital. Her eyes began to feel uncomfortable after leaving the hospital, so she took out her contacts and started rinsing her eyes. She was not feeling better, so she was driven back to the hosp by her husband and was seen at 3:30pm. Proparacaine was instilled for pt comfort and refresh artificial tears were instilled every 10 mins. We prescribed refresh non-preserved artificial tears every 15 mins in both eyes and to f/u the following day ((b)(6)). Pt called this morning ((b)(6)) and said although she felt better, she was still light sensitive and would come in tomorrow ((b)(6)). Pt returned to clinic (b)(6) 2018 and condition had resolved. Therapy date: (b)(6) 2018. Otc product. Frequency: once; route: ophthalmic. Reason for use: contact lens storage. Generic contact lens solution (without bak).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5080183
• MDR Report Key: 7918608
• Date Received: 2018-09-27
• Date of Report: 2018-09-26
• Date of Event: 2018-09-11
• Date Added to Maude: 2018-09-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BAUSCH AND LOMB ADVANCED EYE RELIEF EYE WASH EYE IRRIGATING SOLUTION
• Generic Name: ACCESSORIES, SOLUTION, ULTRASONIC CLEANERS
• Product Code: LYL
• Date Received: 2018-09-27
• Lot Number: GH17027 OR GH17017
• Device Expiration Date: 2019-08-01
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: BAUSCH AND LOMB, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-09-27