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

Model Number	DIU300
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: sections a-2 patient age and date of birth, a-4 patient weight, and a-5 patient ethnicity and race: not applicable as there was no patient contact with the device.Section d-6a date implanted: not applicable as there was no patient contact with the device.Section d-6b date explanted: not applicable as there was no patient contact with the device, therefore not 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.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported during product handling and prior to insertion the pre-loaded diu300 model intraocular lens (iol) re-load was faulty and the optic was crushed.
Additional Manufacturer Narrative
Additional information: the following information was received with device return and section e fields was updated accordingly: section e-1 reporter title: (b)(6); section e-1 reporter first/given name: (b)(6); section e-1 reporter last name: (b)(6); section e-1 reporter telephone number: (b)(6); section e-2 reporter health professional: yes; section e-3 reporter occupation: physician.Section d-9: device available for evaluation: yes; section d-9: device date returned to manufacturer: 18-jul- 2023; section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received taped to paper.The complaint handpiece was received inside of the original folding carton.Visual inspection of the complaint handpiece revealed that it was received with the plunger rod fully advanced.The cartridge could be observed to have viscoelastic residue dispersed throughout the cartridge, suggesting that an adequate amount of ovd was used.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Visual inspection of the lens revealed that the lens was received cut in half.The lens was cleaned and, a scratch on the optic of the lens could be observed.Based on the return condition of the lens, no further production could be performed.Complaint issue dc-device advancement issue was not confirmed.The observed issue dc-cosmetic issues is similar to the complaint issue dc-lens damaged and could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be 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: 17287178
• Report Number: 3012236936-2023-01756
• Device Sequence Number: 20244263
• Product Code: MJP
• UDI-Device Identifier: 05050474747579
• UDI-Public: (01)05050474747579(17)251019
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/04/2023

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: 10/19/2025
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U125
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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