MAUDE Adverse Event Report: TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZKU225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight/ethnicity: unknown, information not provided.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.Therefore, not explanted.Manufacturer phone number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zku225 model intraocular lens (iol) had back haptic broken.There was patient contact with the lens but no medical/surgical interventions such as vitrectomy, incision enlargement or sutures were performed.The procedure was completed successfully using another lens of same model and diopter.Additional details from follow up states that the lens was not inserted into the patient and there was no injury to the patient.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 3/4/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled.Furthermore, a detached haptic was observed.Based on the return condition of the lens, no further evaluation could be performed.The complaint issue could not be confirmed, however the observed detached haptic is similar to the reported complaint issue, but a "broken" haptic is used to describe dc-haptic damaged per amo-04-d024, rev.5 and therefore no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no other complaints from this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• MDR Report Key: 11396753
• Report Number: 9614546-2021-07084
• Device Sequence Number: 11054148
• Product Code: MFK
• UDI-Device Identifier: 05050474687646
• UDI-Public: (01)05050474687646(17)250401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: ZKU225
• Device Catalogue Number: ZKU225U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30- CH15752