MAUDE Adverse Event Report: B&L (BAUSCH & LOMB) B&L RENU (CONTACT LENSE DISINFECTANT, CLEANER, STORAGE SOLUTION

Lot Number GH16018

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Headache (1880); Irritation (1941); Itching Sensation (1943); Swelling (2091); Blurred Vision (2137); Complaint, Ill-Defined (2331)

Event Date 02/02/2017

Event Type  Injury  

Event Description

Dark red, burn-like with severe swelling and irritating, around eye lids, eyebrows, eyelashes at both eyes, blurry vision, in frequent headaches, severe dryness on both eyes and under eyes with constant itch and severe dryness.Made eye doctor's appointment.Returned all b&l renu solutions to (b)(6).I did not run any test myself but corporate was notified by me with their 800 number.Purchased b&l renu solution on (b)(6) 2016 in (b)(6).Otc 2 bottles for (b)(6) plus tax bought on (b)(6) 2016 4:40pm at (b)(6).

• Brand Name: B&L RENU (CONTACT LENSE DISINFECTANT, CLEANER, STORAGE SOLUTION
• Type of Device: B&L RENU (CONTACT LENSE DISINFECTANT, CLEANER, STORAGE SOLUTION
• Manufacturer (Section D): B&L (BAUSCH & LOMB)
• MDR Report Key: 6363836
• MDR Text Key: 68752940
• Report Number: MW5068147
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: GH16018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 61