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

Lot Number 222

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Keratitis (1944); Eye Infections (4466)

Event Date 05/22/2021

Event Type  Injury  

Manufacturer Narrative

The product has been requested but not yet received.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A retailer reported that a consumer experienced slight irritation and stinging in their right eye after contact lens insertion.As the day progressed, they noticed their vision in that eye was becoming cloudy.The consumer removed the lenses from both eyes and the cloudiness remained the right eye.The consumer visited a hospital¿s eye clinic and was diagnosed with bacterial keratitis.Treatment consisted of levofloxacin to be used hourly, day and night for the first forty-eight hours.After the first forty-eight hours the consumer was instructed to continue hourly use of the medication during the day for the next two days.The consumer was seen for a follow up visit at the eye clinic three days later and the medical record confirmed that they had recovered.At the follow up appointment, the consumer was instructed to continue using the levofloxacin every three hours during the day for the next five days and to not wear contact lenses until they were examined by their optician.The consumer saw their optician approximately three weeks later and the optician confirmed that the consumer had fully recovered.

Manufacturer Narrative

The product is no longer available for return.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Additional medical information was received from one of the treating doctors.During the examination the consumer presented with bulbar injection, anterior segment abnormalities, corneal edema and corneal staining in the right eye.A corneal ulcer in the right eye was also observed which the doctor indicated was most likely infectious.The consumer was diagnosed with a microbial keratitis in the right eye.Levofloxacin was prescribed along with temporary suspension of contact lens wear.The patient has now recovered.The doctor believes that the event was caused by contact lens wear.The doctor confirms that the event was not life threatening, it did not result in permanent impairment of a body function or permanent damage to a body structure and it did not necessitate medical or surgical intervention to preclude permanent impairment of a body function of permanent damage to a body structure.

Event Description

Additional medical information has been received.Upon initial examination the doctor believed that the consumer had early contact lens related bacterial keratitis.During the examination the consumer then presented with right eye conjunctivitis and microbial keratitis.During the examination they presented with a visual acuity of bilateral 6/6 best corrected.A second doctor seen confirmed that the event is not life threatening, it did not result in permanent impairment of a body function or permanent damage to a body structure.However it did require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

A review of the manufacturing records found the product met all accepted criteria at the time of manufacturing and distribution of the product.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Manufacturer Narrative

Corrected d1.

• 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 NY 20846 ; IT 20846
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609
• MDR Report Key: 12338701
• MDR Text Key: 267142056
• Report Number: 0001313525-2021-00108
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K020802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention