MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS CL IOL; INTRAOCULAR LENS

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, not provided.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.Device evaluation: product evaluation was not performed because the product has not been returned.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed one additional complaint was received from this production order.But this complaint meets the criteria for no further investigation to be performed.No product malfunction or deficiency could be observed, and no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was opened but not used.The haptic broke while being injected into the eye.It was noted that the iol did touch the patient.It was then cut out and replaced with a new one.It was learned that there was no vitrectomy, sutures, incision enlargement, and no capsule tear.No post-op injuries are reported.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes returned to manufacturer on: 2/25/2021 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 (only one half received), which is consistent with a lens handled during removal and replacement.Haptic damage (bent) was observed on a separated haptic (haptic detached could not be observed because only one half a lens was returned).Based on the return condition of the lens no further product evaluation could be performed.The complaint issue was confirmed, however this can be attributed to handling and cannot be confirmed to be related to manufacturing and no product deficiency could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11313441
• Report Number: 2648035-2021-07238
• Device Sequence Number: 11435082
• Product Code: HQL
• UDI-Device Identifier: 05050474530720
• UDI-Public: (01)05050474530720(17)240819
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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): 03/22/2021

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: 08/19/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1