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

Model Number	DIU150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intraocular lens (iol) did not look or feel right in inserter per doctor.No patient contact.No other information was provided.
Additional Manufacturer Narrative
Weight, ethnicity: unknown/ not provided.Asku.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted, therefore cannot be explanted.The device was not returned for evaluation; 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.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that section g4: combination product box "no" was not marked during the initial submission of report.Therefore, this report is being submitted to correct this.Field below updated: section g4: combination product: no.Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on: 2/8/2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: no complaint lens was received for evaluation.Cartridge tip damage (tear) and cartridge crack (tear) were observed on the handpiece along with plunger rod damage (bent tip).No additional defects or assembly issues were observed before and after disassembling the handpiece for evaluation.The complaint issue ¿dc-lens damaged¿ could not be confirmed because no lens was received for product evaluation.The other observed issues found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16268791
• Report Number: 3012236936-2023-00211
• Device Sequence Number: 15071632
• Product Code: MJP
• UDI-Device Identifier: 05050474746602
• UDI-Public: (01)05050474746602(17)241112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 11/12/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U230
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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 Age: 81 YR
• Patient Sex: Female