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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
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 that a zlb00 22.5 diopter the intraocular lens (iol) was explanted due to the patient experiencing dysphotopsia.The explanted lens was replaced with a model zcb00 22.5.There was no patient injury reported and the patient was doing well post exchange.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site for investigation.Therefore, a product investigation could not be performed and the customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.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 number.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
Additional information: device available for investigation: yes.Returned to manufacturer on: 01/16/2019.Device returned to manufacturer: yes.Device evaluation: the lens was investigated where a visual inspection was performed using magnification.The lens was received inside the lens replacement case.The lens returned was cut in two pieces.Loose fibers/particles were observed on lens pieces and were related to the handling of the unit out of a sterile environment.Viscoelastic residue was also observed on the lens pieces.One of the haptics was observed damaged.No damaged was observed to the other haptic.The condition in which the lens was returned is consistent with a lens that was explanted.The complaint issue reported could not be verified.Based on the results of the investigation, no product deficiency was identified.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.; santa ana CA
• MDR Report Key: 8205390
• Report Number: 3011852734-2018-00247
• Device Sequence Number: 19109230
• Product Code: MFK
• UDI-Device Identifier: 05050474560727
• UDI-Public: (01)05050474560727(17)210907
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 09/07/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 01/28/2019; 10/25/2020
• Initial Report FDA Received Date: 12/30/2018
• Supplement Report FDA Received Date: 01/16/2019; 01/28/2019; 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
• Date Report Sent to FDA: 01/01/2005