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	Blurred Vision (2137); No Code Available (3191)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the returned zlb00 sample was received with original packaging (folding carton) and lens case.A visual inspection was performed to the unit returned and the following were the observations: the lens was cut in two (2) pieces, the two (2) haptics were completed.Residues of viscoelastic were present in the lens surface (implanted & explanted unit).The complaint issue could not be verified.Based on the visual evaluation of the returned unit it could not be determined that the cause of the issue reported is related to the manufacturing process since there are indications the unit was handled and prepared for lens insertion at the surgical stage.A 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 revealed that no additional complaints for this production order number have been received.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 zlb00 21.0 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.It was reported patient was seen (b)(6) 2019 and vision still blurry.Monarch cartridge was used, account was reminded johnson & johnson vision recommends only using jjsv qualified insertions systems as instructed per product directions for use.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.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: 8955156
• Report Number: 2648035-2019-00950
• Device Sequence Number: 11373694
• Product Code: MFK
• UDI-Device Identifier: 05050474560697
• UDI-Public: (01)05050474560697(17)221017
• 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: 10/17/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0210
• 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: 09/03/2019
• 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
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005