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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) had a loading issue, the iol did not bend like a taco.It was noted to bend like a tent.The lens was too thick and haptic got bent.The iol was fully inserted and removed from the left eye during the same procedure and it was replaced with the back-up iol, same model and same diopter power, and one suture was required.No other information was available.
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.
Additional Manufacturer Narrative
Additional information: section d10.Device available for evaluation? yes returned to manufacturer on: 9/9/2020 section h3.Device returned to manufacturer? yes device evaluation: the product was received.It was returned in its original packaging and inside the daisy wheel case insert.Visual inspection performed under microscope: the lens was received cut into pieces with lubricating material residues and loose particles on its surface.Both haptics looks damaged and distorted.Therefore, the reported issues were verified; however, due to the conditions of the sample returned it is not possible to determine the reported issue are related to the manufacturing process or to the handling of the product.Based in the analysis product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from 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.

• 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: 10475363
• Report Number: 2648035-2020-00654
• Device Sequence Number: 19583560
• Product Code: HQL
• UDI-Device Identifier: 05050474529137
• UDI-Public: (01)05050474529137(17)250415
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 10/29/2020
• 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: 04/15/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/21/2020; 10/25/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/15/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CARTRIDGE; UNKNOWN CARTRIDGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005