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

Model Number	ZKB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: if implanted, give date: not applicable, as lens was removed in the initial surgery.If explanted, give date: not applicable, as lens was removed in the initial surgery.It was indicated that the iol is not being returned for evaluation as it was discarded therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if th3191 ere is any further relevant information a supplemental medwatch report will be filed.(b)(4).Device evaluation: product testing could not be performed because the product was not returned as it was discarded.A product quality deficiency could not be confirmed.The reported issue was not verified.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 similar complaints for this production order number have been received.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported when attempting to insert zkb00 30.0 diopter intraocular lens (iol) one of the haptics was broken and while removing the lens was torn resulting in inability to implant a lens.Patient will return when the appropriate lens power arrives.It was reported the zkb00 30.0 diopter iol will not be returned as it was discarded.Through follow up, customer account provided additional information confirming no serious patient injury, no suture(s), and no vitrectomy.It was reported the incision was enlarged, the patient returned (b)(6) 2019 to have zkb00 30.0 diopter lens implanted, and patient outcome was reported as doing well.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 nr-(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: 9431776
• Report Number: 9614546-2019-01089
• Device Sequence Number: 479682
• Product Code: MFK
• UDI-Device Identifier: 05050474560284
• UDI-Public: (01)05050474560284(17)230416
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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: 04/16/2023
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0300
• 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: 11/12/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 11/05/2020
• 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: 78 YR
• Date Report Sent to FDA: 01/01/2005