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

Model Number	ZLB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019 and (b)(6) 2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model zlb00 intraocular lens (iol) was explanted from patient's right eye in a secondary surgical procedure because of mechanical failure of lens.Incision was enlarged to remove the iol from the eye but vitrectomy and sutures were not required.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received from the account indicated that "mechanical failure" is confirmed when patient's symptoms of constant blurry, hazy vision cannot be resolved with spectacle correction.That the patient reported symptoms of constant fuzzy vision at distance and near focal points.The patient reported symptoms of constant glare with driving and inability to see his golf ball clearly to determine the path of the golf ball in flight.A refraction was performed to confirm if any refractive error was contributing to the patient's symptoms of constant fuzzy vision.The minimal refractive error found did not resolve the symptoms of constant fuzzy vision.It was indicated that the symptoms or mechanical failure was noted on (b)(6) 2019.The patient's post operative outcome at the time of discharge was noted to be stable.The following field was updated accordingly: date of event: (b)(6) 2019.(b)(4).Device available for evaluation; returned to manufacturer on: 2/23/2020.Device evaluation: the complaint sample was received in a plastic bag with a lens case identified with a serial number that do not match with the lens returned.However, the customer clarified that the lens returned was the correct lens that they included in the initial report which was explanted.The customer explained that they just put it in a case they have on hand to keep it from getting misplaced.Visual inspection was performed on the lens, under microscope magnification: the lens was received adhered to the lens case.Lubricant material residues and loose particles can be observed on its surface.Both haptics and lens look in good conditions.Due to the conditions of the sample returned the reported issues could not be verified, and product quality deficiency could not be determined.Based on the report on the day the product was measured, the lens was correctly measured with satisfactory result.Manufacturing records review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy and/or deviation found during the mrr (manufacturing record review).The units were manufactured and released according to specifications.A search in complaint system revealed that no additional complaint was received for this production order number.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 nr-(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: 9556476
• Report Number: 2648035-2020-00020
• Device Sequence Number: 14024255
• Product Code: MFK
• UDI-Device Identifier: 05050474560611
• UDI-Public: (01)05050474560611(17)221115
• 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: 2019
• 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): 11/04/2020
• 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: 11/15/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/13/2020; 10/25/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/12/2020; 11/04/2020
• 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: 76 YR
• Date Report Sent to FDA: 01/01/2005