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	Dry Eye(s) (1814); Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between 9/17/2018 and 1/17/2019.(b)(4).Device evaluation: visual inspection with the unaided eye shows that the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Manufacturing record review: the manufacturing process record was evaluated and the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from this production order.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient after being implanted with a zkb00, 22.5 diopter intraocular lens (iol) developed cloudy vision, because of dry eye.The doctor ascertained that lens would not work.The lens was explanted requiring incision enlargement and exchanged for a pcb00 monofocal iol.No other information was provided.
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: 8355943
• Report Number: 9614546-2019-00144
• Device Sequence Number: 2127351
• Product Code: MFK
• UDI-Device Identifier: 05050474560130
• UDI-Public: (01)05050474560130(17)220413
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020
• 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: 04/13/2022
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 11/10/2020
• 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
• Date Report Sent to FDA: 01/01/2005