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

Model Number	PCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after performing a perfectly intraocular lens (iol) implant, the iol went in with a white piece.The piece was removed with the irrigation and aspiration cannula.There was no wound enlargement.And there was no patient injury.No further information has been provided.
Additional Manufacturer Narrative
Age, weight, ethnicity: per eu regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: unknown/not provided.If implanted, give date: unknown /not provided.If explanted, give date: not applicable, there is no indication the lens has been explanted.(b)(6).Initial reporter first/given name: full name not provided.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section h3.Device evaluated manufacturer? yes.Device evaluation: product evaluation could not be performed because the product has not been returned for evaluation.However, evaluation was performed on the photo provided by the customer.The photo shows an implanted lens, and something that appears to be a particle can be seen.The reported issue was verified; however, since there is no sample (e.G.The lens or the device) returned for further evaluation, the reported complaint cannot be confirmed as related or originated during the manufacturing process.The product quality deficiency could not be determined.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: 13691373
• Report Number: 3012236936-2022-00563
• Device Sequence Number: 5170656
• Product Code: HQL
• UDI-Device Identifier: 05050474558335
• UDI-Public: (01)05050474558335(17)240921
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/04/2022

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: 09/21/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000235
• Was Device Available for Evaluation?: No
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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