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 Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant date, explant date: not applicable, as lens was removed/replaced in the initial surgery.Device evaluation: the returned lens was received on 02/20/2019 in a plastic bag.The lens is cut in two pieces most probably related to the removal mentioned on the initial report.The reported issue was verified; however, a product quality deficiency could not be determined.Manufacturing records evaluation: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed that no additional investigation request for this production order number have been received.The directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Results of the investigation revealed there is no indication of a product quality deficiency or a product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a za9003 12.0 intraocular lens (iol) was exchanged.Additional information received reported that the iol was damaged during loading but not noticed until after it was implanted into the left eye.There was not patient injury, no incision enlargement and no vitrectomy performed.A new lens of the same model and diopter was implanted and the patient was doing good post-operatively.No additional information was provided.
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: 8372816
• Report Number: 2648035-2019-00247
• Device Sequence Number: 2287639
• Product Code: HQL
• UDI-Device Identifier: 05050474528857
• UDI-Public: (01)05050474528857(17)230216
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 11/09/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005