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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intraocular lens (iol) had bent/ broken haptic.There was contact with patient's right eye and the issue was noticed while inserting the lens into the eye.The procedure was completed using another lens of same model and diopter and the patient has recovered.No further information was available.
Additional Manufacturer Narrative
Age: unknown, information not provided.Patient weight: unknown, information not provided.Ethnicity/race: unknown, information not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed that one additional complaint was received from this production order which was voided and no escalation was required.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.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: feb 2, 2022.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics.The lens was cleaned, and haptic damage was observed.No further issues were identified.The complaint issue could be confirmed; however, this may be attributed to handling during insertion, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.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: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13375909
• Report Number: 3012236936-2022-00235
• Device Sequence Number: 20069975
• Product Code: HQL
• UDI-Device Identifier: 05050474529076
• UDI-Public: (01)05050474529076(17)250531
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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: 05/31/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/03/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC30 CARTRIDGE, LOT UNKNOWN
• Patient Sex: Female