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

Model Number	ZKB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	08/22/2018
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 zkb00 21.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2018.It was later explanted on (b)(6) 2018 due to patient complaint of seeing the rings of the multifocal lens; he wanted a clear lens without the rings.Zkb00 iol was exchanged and replaced with a non-johnson & johnson iol.Through follow up, customer account provided additional information confirming incision enlargement.There was no complications such as capsule tear, no serious patient injury, no suture(s), no vitrectomy, and patient outcome was reported as fine.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 11/14/2018.Device returned to manufacturer: yes.Device evaluation: the returned sample was received.Visual inspection with the unaided eye shows the product was cut in half, most probably to make explant possible.Considering the condition of the lens, further analysis is not possible.The customer's reported complaint was not verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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(b)(4).

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8031195
• Report Number: 3011852734-2018-00204
• Device Sequence Number: 11121614
• Product Code: MFK
• UDI-Device Identifier: 05050474560116
• UDI-Public: (01)05050474560116(17)210713
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: 07/13/2021
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 10/25/2020
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/13/2018; 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: 72 YR
• Date Report Sent to FDA: 01/01/2005