MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED RENU ADVANCED FORMULA; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 6J19Ø16

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

Patient Problem Vitreous Hemorrhage (2143)

Event Date 05/28/2020

Event Type  Injury  

Event Description

After i corrected the insurance situation, a prescription for contact lenses and solution were filled.As of (b)(6) 2021 no one at (b)(6) hospital' s 3 optometry departments can find a prescription for me.I have been told that my calls have been logged and the "missing" rx noted.When i received the new batch of lenses they caused my cornea to bleed.Later, in (b)(6), when i ran out of contact lenses after failing to obtain the prescription that temple u somehow filled, i resorted to using a pair that temple u gave me.My eyes bled again.During my detainment, i managed to call the fda and issue an adverse reaction complaint to both bausch and lomb and acuvue (johnson and johnson).I have the remaining drops of the saline solution as well as the packaging and sent that into b&l for forensics in (b)(6).This photo is the packaging with the lot numbers for the contact lenses given to me under a fraudulent prescription by dr.(b)(6) and the dispensary staff.

• Brand Name: RENU ADVANCED FORMULA
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 11412803
• MDR Text Key: 238335113
• Report Number: MW5099784
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2021
• Device Lot Number: 6J19Ø16
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability