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

Model Number ZCT400

Device Problem Unintended Movement (3026)

Patient Problems Therapeutic Effects, Unexpected (2099); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date not provided, best estimate is june-july 2020.If explanted, give date: planned explant on (b)(6) 2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) in the patient's right eye is planned to be explanted soon as it rotated 45 degrees from its original position.The patient has blurry vision, uncorrected vision was about 20/50 postop day 1, dropped to 20/200.With correction visual acuity is 20/30.No other information was proved.

Manufacturer Narrative

Upon further follow-up, it was confirmed that the explant was done on 9/14/2020.No adverse events, no patient post-op injuries.Patient fine post-op.Product disposition unknown.Section d7: if explanted, give date: (b)(6) 2020.Device evaluation: product evaluation was not performed because the product has not been returned.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.All pertinent information available to johnson & johnson surgical vision, inc.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 nr-(b)(4) and capa-010215.

• 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: 10463676
• MDR Text Key: 205097548
• Report Number: 2648035-2020-00646
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474553835
• UDI-Public: (01)05050474553835(17)230305
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

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: 03/05/2023
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U160
• 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: 08/12/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/07/2020; 10/25/2020
• Supplement Dates FDA Received: 10/30/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other