MAUDE Adverse Event Report: BAUSCH & LOMB, INC. BIOTRUE ONEDAY DISPOSABLE CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number W67204259

Device Problems Difficult to Open or Remove Packaging Material (2922); Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 08/04/2019

Event Type  Injury  

Event Description

I use the bausch & lomb biotrue one day disposable contact lenses.They are packaged in a strip of 5 lenses which the user must separate.After separating them, the foil covering must be peeled back to access the lens.The problem is that the foil edge is extremely sharp at the front corner where it was previously attached to the next lens.Even when being very careful, it is extremely difficult to avoid being cut by the sharp foil edge.I have been cut multiple times; it probably happens every 3rd or 4th lens.B&l should change the packaging to prevent this.Fda safety report id# (b)(4).

• Brand Name: BIOTRUE ONEDAY DISPOSABLE CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): BAUSCH & LOMB, INC.
• MDR Report Key: 8869415
• MDR Text Key: 153816134
• Report Number: MW5088865
• 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: 08/05/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Lot Number: W67204259
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 113