MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model zmb00 intraocular lens (iol) was explanted from patient''s right eye in a secondary surgical procedure because of dysphotopsia.There was no incision enlargement, vitrectomy or sutures required.The replacement lens used is a model zcb00 but same diopter lens.No additional information was received.
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.
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 5/6/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received in a medical adhesive and was identified with a handwritten label.The lens could not be recovered from the adhesive without damaging the lens, so the lens was inspected as received.Visual inspection with the unaided eye revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed that no other complaints have been received for this production order number.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.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10002740
• Report Number: 9614546-2020-00193
• Device Sequence Number: 16882203
• Product Code: MFK
• UDI-Device Identifier: 05050474535640
• UDI-Public: (01)05050474535640(17)200404
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/08/2020; 10/25/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 06/02/2020; 10/30/2020
• 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: 64 YR
• Date Report Sent to FDA: 01/01/2005