MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED CONTACT LENS SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number R82006014

Device Problem Material Discolored (1170)

Patient Problems Irritation (1941); Twitching (2172)

Event Date 10/08/2020

Event Type  Injury  

Event Description

Reporter stated that he received his contact lenses in orange solution and went ahead and wore them.As a result, he experienced irritation and twitching.When he opened another package, the solution is clear.At that point he contacted the manufacturer, and they admitted that the color should have been clear.They also told him they would send a replacement for the defective device.

• Brand Name: CONTACT LENS SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 10658856
• MDR Text Key: 211117566
• Report Number: MW5097180
• Device Sequence Number: 1
• Product Code: LPM
• Reporter Country Code: US
• PMA/PMN Number: P170035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/07/2021
• Device Lot Number: R82006014
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 100