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

Model Number ZA9003

Device Problem Unintended Movement (3026)

Patient Problems Therapeutic Effects, Unexpected (2099); Vitrectomy (2643); No Code Available (3191)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Expiration date: unknown as product serial number was not provided.Catalogue#: a complete catalogue # is unknown, as product serial number was not provided.Serial#: unknown/not provided udi #: udi # is unknown as product serial number was not provided.(b)(6).Device manufacture date: unknown, as product serial number was not provided.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that following a capsular tear a za9003 intraocular lens (iol) was implanted in the sulcus in a unknown hospital in (b)(6).The patient was dissatisfied and went to amc/oogziekenhuis zonnestraal amsterdam.Because the iol was dislocated, a vitrectomy was performed and the lens was explanted.Follow-up confirmed that no serial number details could be provided and that the explanted iol will be returned.The lens was explanted on the (b)(6) 2019 and the latest visual results were taken on the (b)(6) 2020: 0.5 ; s-3.25+c-1.25 as 90.Following the explant the incision was enlarged for the implantation of an opthec artisan iris fixated iol.Sutures may have been required but the doctor does not remember.As per the surgeon our lens behaved as expected, no product deficiency was reported.No additional information was provided.

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.

Manufacturer Narrative

Section d10 - device available for evaluation? yes.Section d10 - returned to manufacturer on: 10/1/2020.Section h3 - device returned to manufacturer? yes.Device evaluation: visual inspection with unaided eye and also using microscope magnification was performed.The lens was observed with both haptic distorted/bent.This could be related due to the handling for the performed explant of the lens.Residues of viscoelastic were observed at the lens surface.Also, debris and particles were detected related to the lens handling and transit in non-sterile environment.The reported issue could not be confirmed on the return.There is no indication of a product malfunction or quality deficiency.Manufacturing record evaluation: the manufacturing records for the intraocular lens could not be reviewed as no product serial number was provided.Complaint occurrences per serial number: a search of complaints for same issue reported on the catsweb system could not be performed as the lens serial number is unknown.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10475413
• MDR Text Key: 205282534
• Report Number: 2648035-2020-00656
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA9003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention