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

Model Number	PCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Implant date: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Explant date: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Initial reporter name and address: telephone number: (b)(6).Device evaluation: product testing could not be performed since the device 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 product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was either missing a haptic or the haptic had broken off at some point in the loading sequence.The surgeon could not see the missing haptic in the eye.Through follow up we learned that the missing haptic was observed during insertion of the iol.Another lens was placed underneath the damaged lens and the damaged lens was cut to enable removal.Account indicated that the procedure had a 20 minute delay.The patient is reportedly doing fine.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: may 11, 2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: product was returned to the manufacturing site for evaluation.The complaint handpiece was received inside of the original folding carton.No intraocular lens (iol) was received as part of this return.Visual inspection under magnification revealed that the complaint handpiece was received with the lower body broken in half and with the cartridge removed.No issues that could cause or contribute to the complaint issue could be identified.The complaint issues were not confirmed during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.As a result of the investigation, there is no indication of a product quality deficiency.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson and 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: 16738868
• Report Number: 3012236936-2023-00848
• Device Sequence Number: 6862445
• Product Code: HQL
• UDI-Device Identifier: 05050474558298
• UDI-Public: (01)05050474558298(17)251227
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 12/27/2025
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000215
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• 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