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 Code	No Code Available (3191)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zkb00 21.5 diopter intraocular lens (iol) was implanted in the patient¿s operative eye on (b)(6) 2019.The zkb00 lens was explanted on (b)(6) 2019 to improve visual acuity and replaced with a zxt150 22.0 diopter lens.It was reported during the explant process the haptic was pulled off and there was no required medical intervention.Patient outcome was reported as no problems.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 11/05/2019.Section h-3: device evaluated by manufacturer: yes.Section h-3: device returned to manufacturer: yes.Device evaluation: the product was received dry in a jar.The product was disinfected according to procedure.The lens was inspected by a qualified inspector using a 12x magnification microscope.It can be seen that the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.The lens has been cut in most likely to make the explant possible.1 haptic was missing.The edge of the lens is damaged.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.No further anomalies were found.The complaint cannot be confirmed.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 similar complaints for this production order number have been received.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 (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: 9268335
• Report Number: 9614546-2019-01019
• Device Sequence Number: 11278560
• Product Code: MFK
• UDI-Device Identifier: 05050474560116
• UDI-Public: (01)05050474560116(17)221004
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 11/06/2020
• 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: 10/04/2022
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 10/25/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/19/2019; 11/06/2020
• 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: 65 YR
• Date Report Sent to FDA: 01/01/2005