MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BAUSCH & LOMB PUREVISION TORIC; LENSES, SOFT CONTACT, EXTENDED WEAR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Event Description

I am an optometrist at (b)(6) in (b)(6).I do not know the exact date of the incident as the patient did not remember the exact day but knows it happened about 1 year ago.She reported to me that she ordered contact lenses from (b)(6) with an expired contact lens prescription.The patient reports she changed the date on the prescription.However, (b)(6) did not verify her contact lens prescription with us like is federally mandated by law.The patient reports she did receive her contact lenses from them.She has poor compliancy with contact lense use and has corneal problems due to overwear.(b)(6) enables her to continue wearing contacts in an unsafe manner by allowing her to order contact lenses with an expired contact lens prescription.

• Brand Name: BAUSCH & LOMB PUREVISION TORIC
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 8392407
• MDR Text Key: 137963310
• Report Number: MW5084654
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR