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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown, information not provided.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that upon insertion of a z9002 model intraocular lens (iol) into the patient's operative eye it was observed that a haptic had broken off from the lens.Procedure was completed successfully using a backup lens.There was no patient injury and no medical/ surgical interventions were done.No further information available.
Additional Manufacturer Narrative
Corrected data: new information received written on the box which contained the product return that there was cracked haptic.This correction is submitted as initial report submitted had a device code of 1261.Therefore, this field is updated: section h6: medical device problem code: 1069.Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 11/11/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under a magnification revealed viscoelastic residue on the optic body and haptics.The lens was cleaned, and the optic body was observed to be torn.No findings on the haptics.The complaint issue could not be confirmed and 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 two complaints from this production order number, however the reported issue is unrelated to this reported complaint and no product deficiency was identified in that case.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 CL IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12669259
• Report Number: 2020664-2021-07821
• Device Sequence Number: 1231194
• Product Code: HQL
• UDI-Device Identifier: 05050474530720
• UDI-Public: (01)05050474530720(17)260115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: 01/15/2026
• Device Model Number: Z9002
• Device Catalogue Number: Z900200215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown