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	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: best estimate date is between (b)(6) 2019 - (b)(6) 2019.(b)(4).The product testing could not be performed as the product was not returned.The reported complaint could not be verified.The manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.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 that a model zmb00 22.0 diopter intraocular lens (iol) was explanted from the patient¿s operative eye due to power discrepancy-unexpected post-op refraction, and blurry vision.Per the customer, there was nothing wrong with the explanted iol.The iol was replaced with the same model lens but lower diopter (19.5).The following visual acuity measurements were provided.Visual acuity pre-operative: 20/70 uncorrected.Visual acuity post-operative: 20/50 uncorrected day 1 post-op.No further information was provided.
Additional Manufacturer Narrative
Corrected data: reason for non-evaluation of the initial mdr was inadvertently populated with code 02.This was incorrect as a device evaluation was provided in the form of a manufacturing record review and historical review.Additional information: device available for evaluation, yes.Returned to manufacturer on 10/10/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.A visual inspection of the returned lens shows it was cut into four pieces, most probably to aid in the explant.Based on the condition of the return, further analysis is not possible.The reported complaint issue could not be confirmed.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 & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9182789
• Report Number: 3011852734-2019-00189
• Device Sequence Number: 2693064
• Product Code: MFK
• UDI-Device Identifier: 05050474535664
• UDI-Public: (01)05050474535664(17)210915
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2021
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 10/25/2020
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/22/2019; 11/10/2020
• 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