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

Model Number	DIU225
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: sections a-2 patient age/date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6b date explanted: not applicable as there is no indication the iol was explanted.Section h3-81: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported while implanting the pre-loaded diu225 model intraocular lens (iol) into the patient's operative eye, a small plastic sharp barb on each lateral edge of the cartridge was observed.Insertion of the iol went fine and the case concluded uneventfully.There was no patient issues and no medical or surgical intervention was required.Patient status post-procedure is unknown.Doctor is concerned having sharp edges that may come into contact with the capsule or catch in the edge of the incision.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: device date returned to manufacturer: 18-dec-2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the suspect handpiece was received in a baggy.Visual inspection of the suspect handpiece found the handpiece was received fully advanced, stress marks and a bulge at the cartridge tip.This is consistent with a product that was used.Insufficient ophthalmic viscosurgical device ¿ viscoelastic (ovd) residue was also observed.No issues that could contribute to the complaint issue were observed, and no further issues were identified.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was identified.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: 18323499
• Report Number: 3012236936-2023-03177
• Device Sequence Number: 12519200
• Product Code: MJP
• UDI-Device Identifier: 05050474747029
• UDI-Public: (01)05050474747029(17)260427
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 04/27/2026
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U145
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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