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

Lot Number 222

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

Patient Problems Corneal Ulcer (1796); Keratitis (1944); Eye Infections (4466)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

The product is not available for return for evaluation and a lot number could not be provided based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A consumer reported to their retailer that they experienced an eye infection after using the product.The consumer wore their contact lenses both day and night.The consumer visited the emergency department with complaints of right eye redness, pain and foreign body sensation within 24 hours after inserting new lenses.The lenses were removed and the pain was partially relieved, although their eyes were still red and watering.The patient denied any change in vision.A slit lamp examination showed the conjunctiva and sclera were red and injected.Their cornea, a/c and pupils/iris were in no apparent distress.Fluorescein was instilled and showed a small uptake of stain at 7o''clock.Doctor¿s impression was mild keratitis of the right eye.The patient was diagnosed with corneal ulcers.The patient was treated with chloramphenicol 1% eye ointment and advised to temporarily discontinue contact lens wear.The patient visited an eye hospital two days later and showed right eye injected, corneal diffuse staining and epithelial irregularity 5 o''clock.The patient also indicated they felt as if they were ''looking through a veil''.Microbial keratitis was suspected.There is no ac cells, dilated exam was normal.Doctor¿s impression was right eye contact lens related keratitis, diffuse keratitis with epithelial irregularity at 5 o''clock, atypical.There was improvement with the treatment, however the patient was swabbed for acanthamoeba in which the results were negative.They were instructed to use ofloxacin 2 hours and hyloforte regularly.Patient has since recovered.

• Brand Name: RENU SENS. 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: 12746712
• MDR Text Key: 279927373
• Report Number: 0001313525-2021-00134
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K982775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention