MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zkb00, 19.0 diopter intraocular lens (iol) was implanted into the patient right eye.Post-operatively, the results were not as intended.The patient complained of blurred vision and could not read.There were no injuries and no additional intervention was performed.At the 1-month post-op visit, the patient was 20/40-1 uncorrected visual acuity (ucva); +1.00+0.25x35 manifest refraction, +0.75+0.50x39 auto refraction.Uncorrected vision near (ucvn) was j10 @ 16 inches.Best corrected final visual acuity (va) was 20/25; final near va was j1-1 @ 16 inches, distance 20/25.It was reported there was no malfunction with the iol.The surgeon then performed an iol exchange to a zkb00, 21.0 diopter size.No report of incision enlargement, vitrectomy and sutures done.No patient post-op injury.No additional information was provided.
Additional Manufacturer Narrative
New information received and it was learned that the incision was enlarged very slightly during the explant.The customer could not remember if a stitch/suture was used.Also, it was learnt that the patient was 20/30 uncorrected (uc), j2 at one week post op.At four weeks post-exchange, the patient is happy and has had no issues with the computer or dashboard with the newly implanted model zkb00 lens.Plan is to use a model zlboo for the second eye to achieve better near reading vision.Patient code 3191: incision enlargement.Device available for evaluation ¿ yes, returned to manufacturer on 6/12/2019.Device returned to manufacturer ¿ yes.Device evaluation: the returned sample was received within its replacement lens¿ daisy wheel kept inside of a plastic jar.A visual inspection of the lens showed trace of ophthalmic viscosurgical device (ovd) as well as a scratch across the optic surface.The lens was cleaned with purified water and dried with compressed air to ease inspection.Further inspection under magnification shows a small cut on the lens, most probably made to aid in explant.The reported issue could not be 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 other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported 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: 8630149
• Report Number: 3011852734-2019-00110
• Device Sequence Number: 11266970
• Product Code: MFK
• UDI-Device Identifier: 05050474560062
• UDI-Public: (01)05050474560062(17)210704
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 11/12/2020
• 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: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/07/2019; 10/25/2020
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/03/2019; 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
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005