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); Vitrectomy (2643); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date of event is unknown best estimate is between (b)(6) 2015(implant date)- (b)(6) 2019 (explant date).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zmb00 22.0 diopter intraocular lens (iol) was implanted on (b)(6) 2015.It was later explanted on (b)(6) 2019, because the patient was unable to accommodate the multifocal lens.There was a vitrectomy required and the incision was enlarged.The replacement was a non-jjsv lens.Patient outcome was noted as fine.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that ''unable to accommodate multifocal lens'' was defined as patient reporting she had difficulty driving and reading due to blurred vision after cataract surgery.At her one day post op visit 1/22/2015, she complained of blurry vision 20/30.Patient doing well after explant, vision 20/25.Right eye.Date of event: (b)(6) 2015 device returned to manufacturer: no.Patient code: 2137- blurred/ blurry vision.Device evaluation: product testing could not be performed because the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing record records was evaluated and this revealed that the product was manufactured according to specification.A complaint history search was performed and revealed that no similar complaints were 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 (b)(4) 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: 8589079
• Report Number: 9614546-2019-00432
• Device Sequence Number: 13912456
• Product Code: MFK
• UDI-Device Identifier: 05050474535664
• UDI-Public: (01)05050474535664(17)180323
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 03/23/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 10/25/2020
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/06/2019; 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