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	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported a zkb00 15.0 diopter intraocular lens (iol) was implanted in the patient's eye on (b)(6) 2018.It was later explanted on (b)(6) 2019 due to hyperopic shift.The procedure was completed successfully with another zkb00 lens with a higher diopter.There is no incision enlargement or suture needed.The patient is doing well post-operatively.No further information was provided.Patient has bilateral implants.This report represents the right eye.The left eye will be submitted under a separate report.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 7/2/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site in a little jar.The product is inspected by a qualified inspector using a microscope with a 12x magnification.It can be seen that there is a mark on optic body from the forceps that was used.In addition, the lens is damaged on both sides.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.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 of complaints revealed no similar complaints were received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product 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 (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: 8702085
• Report Number: 9614546-2019-00552
• Device Sequence Number: 19421652
• Product Code: MFK
• UDI-Device Identifier: 05050474559981
• UDI-Public: (01)05050474559981(17)190615
• 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: 2018
• 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): 11/12/2020
• 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: 06/15/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 10/25/2020
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/09/2019; 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: 70 YR
• Date Report Sent to FDA: 01/01/2005