MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED RENU FRESH MULTI-PURPOSE SOL.(MILAN); ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 222

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

Patient Problems Conjunctivitis (1784); Inflammation (1932); Uveitis (2122)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

The product is not available for evaluation as it was discarded.A review of the lot batch records concluded that the product was formulated and manufactured according to local and global specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.The investigation is ongoing.

Event Description

A distributor reported a consumer was diagnosed with conjunctivitis while using the product.Follow-up with the consumer provided additional information.The consumer reported they were diagnosed with keratoconjuntivitis after visiting a doctor.The consumer was prescribed floxal drops every hour and an unknown ointment for nighttime.Medical records indicate that at the follow-up visit on the next day, the consumer''s right lids were calm and weak injection on the conjunctiva was present.Consumer was diagnosed with keratitis and uveitis.At the follow-up visit with eye care practitioner, consumer was instructed to continue using floxal drops, the unknown ointment for nighttime use, and tobrex drops were added.

Manufacturer Narrative

The product is not available for evaluation as it was discarded.A review of the lot batch records and testing of retain samples concluded that this product was formulated, manufactured, and packaged according to local and global product specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: RENU FRESH MULTI-PURPOSE SOL.(MILAN)
• 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-IOM S.P.A; via pasubio 34; 20050 macherio; milan 20846 ; IT 20846
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609
• MDR Report Key: 12508640
• MDR Text Key: 272548174
• Report Number: 0001313525-2021-00119
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: EZ
• PMA/PMN Number: K020802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2022
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male