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

Model Number	ZA9003
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown.Sex/gender: unknown.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was implanted and removed during same-day procedure as the lens would not hold in the patient's sulcus.There was no replacement lens at that time.The patient required an incision enlargement, sutures, and a vitrectomy.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional info: further information was provided and reported there was no replacement lens.The following sections have been updated accordingly: age/date of birth: (b)(6).Sex/gender: male.(b)(6), health professional, occupation: physician.Additional info: device available for evaluation; returned to manufacturer on: 9/4/2019.Device evaluation: lubricant material residues can be observed on the lens surface.The lens was cut into pieces, which could be related to the removal process.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional 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 capa-010215.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8964422
• Report Number: 2648035-2019-00969
• Device Sequence Number: 2444622
• Product Code: HQL
• UDI-Device Identifier: 05050474529090
• UDI-Public: (01)05050474529090(17)210621
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 10/25/2020
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/01/2019; 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005