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

Model Number	ZMA00
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that lens was explanted due to missing haptic when lens got implanted in patient right eye.Haptic stayed in the cartridge hinge.There was incision enlargement from 2.2 mm to 3.0 mm.Suture was used because of the incident.Vitrectomy was performed.Patient was doing fine post-op.No further information provided.
Additional Manufacturer Narrative
Section d10: device available for evaluation ¿ yes, returned to manufacturer on 11/5/2019 section h3: device returned to manufacturer ¿ yes.Device evaluation: the product was received in a lens case.The product was disinfected according to procedure wv0491.The product was inspected by a qualified inspector using a 12x magnification.It can be seen that the optic body has been cut, and 2 scratches are present on the posterior side of the lens.The damaged was most probable introduced during explant of the lens.In addition it can be seen that both haptics are bent.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints were received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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 (b)(4) and capa-010215.

• Brand Name: TECNIS
• 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: 9132198
• Report Number: 9614546-2019-00928
• Device Sequence Number: 16949158
• Product Code: MFK
• UDI-Device Identifier: 05050474536838
• UDI-Public: (01)05050474536838(17)200312
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 03/12/2020
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/06/2019; 10/25/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/07/2019; 11/10/2020
• 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: 64 YR
• Date Report Sent to FDA: 01/01/2005