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

Model Number ZCT300

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019.If explanted, give date: not applicable, as lens remains implanted.The device is not returning for evaluation as to date it remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the zct300 intraocular lens (iol) was implanted into the patients right eye as the replacement lens during an iol explant procedure.There were no complication at the time of surgery but the iol was found to have rotated 90 degrees (to 180º instead of 90º).A repositioning of the iol has been scheduled.No additional information was received.This report captures the reported event with the iol reported as having rotated.The explanted lens event is being reported in a separate mdr.

Manufacturer Narrative

Corrected data: upon review of the folder, it was discovered that the address of the reporter provided in the initial mdr was incorrect reported.As a result, the following fields have been updated.Section e1: facility name - (b)(6) hospital.Section e1: address line 1 - (b)(6).Section e1: city - (b)(6).Section e1: state - (b)(6).Section e1: postal code - (b)(6).Section e1: phone - (b)(6).Additional information: through follow-up additional information was provided: rotation was first observed the day after surgery - (b)(6) 2019.The repositioning was conducted on (b)(6) 2019.There were no other medical or surgical intervention required, and the patient is doing fine.The following field is now populated: section b3: date of event - (b)(6) 2019.Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.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-0148919 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: 9604685
• MDR Text Key: 179625126
• Report Number: 9614546-2020-00027
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474553224
• UDI-Public: (01)05050474553224(17)200308
• 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: 01/01/2005,11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U150
• 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: 12/26/2019
• Initial Date FDA Received: 01/18/2020
• Supplement Dates Manufacturer Received: 02/04/2020; 10/25/2020
• Supplement Dates FDA Received: 03/04/2020; 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR