MAUDE Adverse Event Report: BAUSCH & LOMB INC. BAUSCH & LOMB PURE VISION MULTI FOCAL CONTACT LENS; LENS SOFT CONTACT DAILY WEAR

Lot Number R88526803

Device Problem Defective Component (2292)

Patient Problems Foreign Body Sensation in Eye (1869); Pain (1994); Discomfort (2330)

Event Date 08/01/2019

Event Type  Injury  

Event Description

New box of bausch & lomb pure vision multi-focal lenses.Box of 6, so far opened 3 of the 6 and they feel like sand in my eye.B&l will not replace the box, they state i have to insert all lenses from the box despite causing pain and discomfort before they will replace.They replaced 2 of the 6 so far (a 3rd was tried today and caused pain).The box is clearly defective and they refuse to address it until i have inserted each and every one of them.Lenses from a different box (same brand) are fine.(b)(4).

• Brand Name: BAUSCH & LOMB PURE VISION MULTI FOCAL CONTACT LENS
• Type of Device: LENS SOFT CONTACT DAILY WEAR
• Manufacturer (Section D): BAUSCH & LOMB INC.
• MDR Report Key: 8860868
• MDR Text Key: 153392969
• Report Number: MW5088727
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/01/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/18/2021
• Device Lot Number: R88526803
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 91