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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown/not provided, but best estimate date is between (b)(6) 2019 - (b)(6) 2019.(b)(4).Device evaluation: the lens was kept inside a plastic sample jar labelled with the patient¿s information.A visual inspection of the lens shows it was cut in half and one haptic was detached and stuck to the two halves.Based on the condition of the return, further analysis is not possible.The complaint event is not confirmed.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 similar complaints were received from this production order.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.
Event or Problem Description
It was reported post-implant of a model zmb00 22.5 diopter intraocular lens, the patient experienced unexpected post-op refraction due to a discrepancy in lens power.The lens was explanted on (b)(6) 2019 and successfully replaced with another zmb00 of a lower diopter (21.0).There was no incision enlargement, vitrectomy or sutures required.No patient injury reported.Outcome was noted to be normal.No additional information 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: 8635075
• Report Number: 3011852734-2019-00112
• Device Sequence Number: 1821580
• Product Code: MFK
• UDI-Device Identifier: 05050474535671
• UDI-Public: (01)05050474535671(17)210513
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020
• 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: No Information
• Device Expiration Date: 05/13/2021
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 11/12/2020
• 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