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

Model Number ZCT225

Device Problem Unintended Movement (3026)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Expiration date: unknown, as lot number was not provided.Udi # is unknown as product lot number was not provided.Manufacture date: unknown, as lot number not provided (b)(4).Device evaluation: product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records review for the product could not be performed since serial number is unknown.Conclusion: since the lens was not returned, the complaint issue reported could not be verified.Product deficiency could not be determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol), model and diopter unknown, rotated in the patient¿s operative eye.Consequently, the patient had a little myopic surprise.The doctor plans on exchanging the lens instead of rotating it back into position.No further information was provided.

Manufacturer Narrative

Additional information: the axis of implantation 29 degrees.One day post-op vision was within normal range but noted to be decreased from expected at post-op week 1 visit (20/70 uncorrected).The patient was dilated that day ((b)(6) 2019) and the iol was noted to be rotated to ~90 degrees.There were no enlargement of incision, no capsular tear, no vitrectomy and no sutures.(b)(4).Additionally, product identifiers were provided, therefore, the following fields have been updated accordingly: age/date of birth: (b)(6).Brand name: tecnis, procode: hql previously reported as mfk, common device name: toric iols, model#: zct225, catalog#: zct225u210, expiration date: 11/28/2022, serial#: (b)(4), udi#: (b)(4), implanted date: (b)(6) 2019.Device manufacture date: 11/28/2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device evaluation: product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for 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

Additional information: section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 01/30/2020.Section h3: device returned to manufacturer: yes.Section h6: results code: 114.Device evaluation: the return sample was received.The product was received in a little jar with fluid.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.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: 9231390
• MDR Text Key: 163633303
• Report Number: 2648035-2019-01124
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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,Followup,Followup
• Report Date: 01/01/2005,11/06/2020

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: 11/28/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• 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: 10/16/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 10/28/2019; 11/25/2019; 09/02/2020; 10/25/2020
• Supplement Dates FDA Received: 11/23/2019; 11/28/2019; 09/15/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention