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

Model Number	ZKB00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Vitrectomy (2643); No Code Available (3191)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: explant was scheduled on (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 after the implantation of the zkb00 multifocal iol (intraocular lens) the patient experienced blurry vision.Reportedly a mild subluxation nasally of the implanted lens was noticed.As a result, the lens was planned to be explanted on (b)(6) 2019.Patient's visual acuity pre-operative: 20/40; patient's visual acuity post-operative: 20/60.No additional information was proved.
Additional Manufacturer Narrative
Based on new information received, lens was explanted on (b)(6) 2019 and was replaced with lens model: za9003 +20.5 diopter.Reportedly, anterior vitrectomy was performed, but no patient injury.Patient was also stable when discharged.Further follow information received; the nurse in charge of or responded that 2 lenses were both discarded and were not available for investigation.Lens with corresponding serial number: (sn), (b)(4) was cut in half and explanted, then discarded.The other lens model: zkb00 with sn: (b)(4) was also discarded.The nurse indicated that the doctor first implanted lens with sn: (b)(4) on (b)(6) 2019 which is on the same day it was removed and replaced with lens sn: (b)(4) with explanted date on (b)(6) 2019.The first lens was removed and replaced and the nurse did not know the reason of lens removal.The nurse will talk to the doctor tomorrow.He will call and provide us the reason for the removal/replacement of the first lens.The following fields have been updated accordingly: implant date: if explanted; give date: on (b)(6) 2019.Patient code 3191 - updated planned explant to explant.Device evaluation: the product testing could not be performed as the product has been discarded.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions 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.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-0148919 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: 8411719
• Report Number: 9614546-2019-00213
• Device Sequence Number: 11211537
• Product Code: MFK
• UDI-Device Identifier: 05050474560109
• UDI-Public: (01)05050474560109(17)221002
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 10/25/2020
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/10/2019; 11/11/2020
• 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: 74 YR
• Date Report Sent to FDA: 01/01/2005