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	Visual Impairment (2138); Vitrectomy (2643); No Code Available (3191)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional/similar (as applicable) complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed, the dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model zkb00 22.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2017.The lens was explanted on (b)(6) 2019 due to patient not being happy with his visual acuity after surgery.The iol had pits from the yttrium aluminum garnet (yag) laser procedure.The patient also had retina surgery after the initial cataract surgery and has silicone oil placed in the eye.There was no patient injury, no incision enlargement.The replacement lens was a johnson & johnson surgical vision, model za9003 22.5 diopter lens, vitrectomy was performed.The patient¿s visual acuity has improved with an uncorrected vision of 20/50+2.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Corrected data in review of the report, it was noted that in the initial emdr submission, the statement entered regarding historical data analysis was worded incorrectly, the comment should have stated: a search revealed that no other complaints for this production order number have been received.Additional information device available for evaluation: yes.Returned to manufacturer on: 05/13/2019.Device returned to manufacturer: yes.Device evaluation: a visual inspection of the lens shows it was cut through the optic center most probably to aid in explant.One haptic was detached and missing and traces of ovd were present on the lens surfaces.The lens was cleaned with purified water and dried with compressed air to ease inspection.Further inspection under microscope did not reveal any additional defects.Based on the condition of the lens, further analysis is not possible.The complaint event is not confirmed.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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 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: 8601126
• Report Number: 3011852734-2019-00104
• Device Sequence Number: 16660412
• Product Code: MFK
• UDI-Device Identifier: 05050474560130
• UDI-Public: (01)05050474560130(17)210517
• 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: 2017
• 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: 05/17/2021
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 10/25/2020
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/11/2019; 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: 69 YR
• Date Report Sent to FDA: 01/01/2005