MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number ZCT450

Device Problem Unintended Movement (3026)

Patient Problem Blurred Vision (2137)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

If explanted, give date: not applicable, as lens remains implanted.Device evaluation: product evaluation was not preformed because per the initial report the lens is still implanted in the patient's eye.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Note: the device was manufactured at the kulim site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a zct450 intraocular lens (iol) was implanted in the patient¿s right eye.In one week post op appointment he was informed that lens was not at the right angle.It was noted that the patient has his 8th week appointment soon, and he wants to gather the correct questions to ask the dr.When he meets with him.He is curious about what the statistics are about percentage of lenses that need rotation adjustments.It was learned that the patient¿s right eye has been blurry since post-op but had never improved or even gotten worse and when the doctor checked him one week post-op that's when they found out that his lens moved.The doctor has mentioned to him about lens reposition but patient is concerned of complications hence he called for some advise.Further follow-up with the doctor confirmed that the toric iol has moved approximately 40 degrees from intended position.The doctor offered to move the lens implant but the patient declined to have further surgery.Because he is going to have to wear glasses to correct the fellow eye to 20/20, the patient chose to just leave things alone.No other information was provided.

Manufacturer Narrative

Corrected data: upon further review it was discovered that in the initial mdr, method code was inadvertently indicated.The lens remains implanted.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and (b)(4).

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9388382
• MDR Text Key: 168457742
• Report Number: 2020664-2019-00018
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474602823
• UDI-Public: (01)05050474602823(17)230612
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

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: Health Professional
• Device Expiration Date: 06/12/2023
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/28/2019
• Supplement Dates Manufacturer Received: 11/27/2019; 10/25/2020
• Supplement Dates FDA Received: 12/02/2019; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other