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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
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 zlb00, 23.0 diopter intraocular lens (iol) was explanted due to unexpected post-op refraction.There was no incision enlargement, no vitrectomy and no sutures performed.There was no post-op injury.Replacement lens was another zlb00 of a higher diopter (24.0).No other information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 12/31/2018.Device returned to manufacturer ¿ yes.Device evaluation: the returned lens was identified by the operative eye noted on the return container.The lens was inspected with the unaided eye showing it was cut in half most probably to aid in explant.Due to the condition of the lens, further analysis is not possible.The complaint event could not be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specifications.A search in complaint history was performed which revealed that no similar complaint has been received for this production order number.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.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.
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 AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8177771
• Report Number: 3011852734-2018-00233
• Device Sequence Number: 11152578
• Product Code: MFK
• UDI-Device Identifier: 05050474560734
• UDI-Public: (01)05050474560734(17)220308
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 03/08/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/22/2019; 10/25/2020
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/14/2019; 11/05/2020
• 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