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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after insertion of a model za9003 intraocular lens (iol) into the patient's right eye, the haptic broke off and the capsular bag tore.The lens was not replaced as the patient's capsular bag was not stable enough.There was no vitrectomy, incision enlargement or sutures required.The patient is doing well.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device evaluation: the device was not returned at the manufacturing site; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified.A search of complaints revealed two other complaints were received under this production order; however the reported issues are unrelated to this complaint type and they required no investigation.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 nr-0148919 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: 9846200
• Report Number: 2648035-2020-00259
• Device Sequence Number: 2886991
• Product Code: HQL
• UDI-Device Identifier: 05050474529090
• UDI-Public: (01)05050474529090(17)220222
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 11/02/2020
• 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: 02/22/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 10/25/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/24/2020; 11/02/2020
• 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: Other
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005