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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date not provided, best estimate is between (b)(6) 2019.(b)(4).Device evaluation: the complaint unit was received in a plastic bag with the wheel case insert.Visual inspection at microscope magnification was performed.Only a half of lens was received.Lubricants material residues and loose particles can be observed on the lens surface.Due to the conditions in which the sample was returned the reported issues could not be verified, and product quality deficiency could not be determined.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 that one (01) additional complaint was received from this production order for the same issue and serial number, however it was cancelled as it was duplicate.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.Attempts were made to contact the customer account requesting additional information however, to date no response has been received all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported a model zlb00 19.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2019.Iol was explanted on (b)(6) 2019 due to complaints of unable to tolerate poor intermediate vision.Zlb00 lens was replaced with zkb00 lens.No additional information was provided to johnson & johnson surgical vision.
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: 8963627
• Report Number: 2648035-2019-00964
• Device Sequence Number: 16682141
• Product Code: MFK
• UDI-Device Identifier: 05050474560666
• UDI-Public: (01)05050474560666(17)221011
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020
• 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: 10/11/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 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
• Date Report Sent to FDA: 01/01/2005