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

Model Number	ZKB00
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019 and (b)(6) 2020.(b)(4).Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.A visual inspection under magnification revealed debris/fibers on the lens optic and haptics, which can be attributed to the lens being returned wrapped in gauze, however how and when these defects occurred cannot be confirmed.After cleaning the lens, the debris/fibers were no longer observed.Additionally, 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 further evaluation could be performed.The complaint issue could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.The device was manufactured at the (b)(4) site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the zkb00 intraocular lens (iol) was explanted from the patients right eye due to the wrong power.There was no patient injury and no surgical intervention.The patient was doing okay post-op.A request was made for additional information but 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 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: 9710147
• Report Number: 2020664-2020-00016
• Device Sequence Number: 16926209
• Product Code: MFK
• UDI-Device Identifier: 05050474560185
• UDI-Public: (01)05050474560185(17)210705
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• 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: 07/05/2021
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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
• Date Report Sent to FDA: 01/01/2005