MAUDE Adverse Event Report: JOHNSON & 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 Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	12/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided, however it was reported that symptoms became bothersome two months post-implant, therefore (b)(6) 2013 is entered.(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 implanted in the patient's eye and the patient was not happy as patient could not focus correctly especially when driving.The patient also complained vision was blurry, hazy, and colors were not rigid.The visual issues became bothersome two months post-implant.The patient was intolerant to the multifocal lens exacerbated by astigmatism caused by the flattening from the femtosecond laser arc.A vitrectomy was required as well as limbal relaxation incisions, however, there was no patient injury.The lens was explanted and replaced with a non-johnson & johnson replacement lens.The patient's vision has improved.The glare and halos have decreased.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: in reviewing the initial mdr, it was noticed that the following information were addressed inappropriately in section b3 and d6 with the incorrect year.The following sections have been updated accordingly: section b3: 2016.Section d6: 2016.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 3/16/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: visual inspection with the unaided eye revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaints for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 9874406
• Report Number: 9614546-2020-00140
• Device Sequence Number: 11501203
• Product Code: MFK
• UDI-Device Identifier: 05050474560734
• UDI-Public: (01)05050474560734(17)200302
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 03/02/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 04/15/2020; 10/25/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/14/2020; 05/07/2020; 10/30/2020
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005