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

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Vitrectomy (2643); No Code Available (3191)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that tecnis multifocal intraocular lens (model zma00 +24.0 diopter) was explanted from patient¿s left eye because of patient experiencing mechanical failure.Additional information was received, and it was learnt that the mechanical failure symptoms reported were distorted vision at distance and near with a constant wide line of light in middle of vision.The symptoms could not be resolved.Reportedly lens with model z9002 and higher diopter of +25.0 was used as replacement for the patient.During the procedure vitrectomy was required.Patient reported good post operative outcome with improved vision.No further information provided.
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 4/14/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is damaged, most probably to make explant possible.The lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.The search revealed that no similar complaints were 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 and johnson surgical vision 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
• 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: 9895030
• Report Number: 9614546-2020-00158
• Device Sequence Number: 13628583
• Product Code: MFK
• UDI-Device Identifier: 05050474536883
• UDI-Public: (01)05050474536883(17)221110
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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: 11/20/2022
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/29/2020; 10/25/2020
• Initial Report FDA Received Date: 03/29/2020
• Supplement Report FDA Received Date: 04/30/2020; 11/02/2020
• 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: 77 YR
• Date Report Sent to FDA: 01/01/2005