MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. INTRAOCULAR LENS

Model Number DIBOO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Dizziness (2194)

Event Date 12/29/2021

Event Type  Injury  

Event Description

Blur and distortion with distance vision - johnson & johnson tecnis eyhance (diboo) lens implanted after cataract surgery - overall vision is subpar, but driving has become extremely challenging.Doctor contends amd is my problem and that lens exchange will not improve my vision.However, j&j literature clearly states this kind of problem can develop in patients implanted with the diboo lens; i.E., the lens can seriously impair distance vision finding a competent physician to do the iol exchange is difficult and insurance does not want to cover the cost.Medicare and bcbs refuse to pay.Office visual acuity test turn out acceptable and is the reason insurance will not pay for an exchange.Visual acuity on the road cannot be measured, but can only be described as distortion seen in other automobiles on the road and blur to the extent i get dizzy and driving becomes dangerous.No office visual acuity test can demonstrate my problem.Fda safety report id #(b)(4).

• Brand Name: INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 14160300
• MDR Text Key: 289766912
• Report Number: MW5109153
• Device Sequence Number: 1
• Product Code: HQL
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/29/2021
• Device Model Number: DIBOO
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BUSPAR; CHORTRIMETON ALLERGY MEDICATION; LOSARTAN; PERSERVISION VITAMINS; TOPROL
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White