MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BOSTON REWETTING DROPS; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Insufficient Information (3190)

Patient Problems Corneal Abrasion (1789); Iritis (1940); Pain (1994); Red Eye(s) (2038); Corneal Infiltrates (2231); Excessive Tear Production (2235)

Event Type  Injury  

Manufacturer Narrative

Product was not available to be returned for analysis and lot information was not available.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A staff member from a hospital, located in (b)(6) 2019, reported that a total of 5 patients, over various days, came into the hospital with symptoms of red eyes, pain, tearing and symptoms of corneal abrasions after use of their rigid gas permeable contact lenses.The patients were diagnosed with 1 or 3 points of thick punctate corneal infiltration complicated with iritis of different degrees.All patients were advised to stop using all products and were actively treated.The names and duration of treatment were not provided.It was reported that most of the patients recovered, however, a few of the patients had residual caligo corneae at the time of the report.The hospital stated that all patients were compliant with contact lens wear.Additional information, including individual identifiers of the patients, is not available as the hospital refused to provide.

• Brand Name: BOSTON REWETTING DROPS
• 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; 8507 pelham road; greenville SC 29615
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 9292942
• MDR Text Key: 174298060
• Report Number: 0001313525-2019-00180
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P820070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/07/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization