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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the pre-loaded dib00 intraocular lens (iol) was defective.Patient was unable to be still, there was no patient contact.No further information is available.
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 b-3: date of event: unknown as information was not provided.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted, 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.
Additional Manufacturer Narrative
Additional information: with device return the following information was received and the following fields were updated accordingly: section a-2 patient date of birth: (b)(6) 1954.Section a-3 patient gender: male.Section b-3 event date: aug 25, 2021.Section e-1 title: dr.Section e-1 first/given name:(b)(6).Section e-1 middle name: (b)(6).Section e-1 last name: (b)(6).Section e-2 health professional: yes.Section e-3 occupation: physician.Section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 03-may-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens and handpiece were received inside of the original folding carton.Visual inspection under magnification revealed that the complaint handpiece was received with the lens inside of the base of the cartridge and overridden by the plunger rod.The lens could be observed to be rotated counter clockwise and trace amounts of viscoelastic residue were observed inside of the cartridge, suggesting that an inadequate amount of ovd may have contributed to the observed issues.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint or observed issue could be identified.The lens was removed from the cartridge and cleaned, revealed a chipped edge consistent with a lens that was overridden.Complaint issue "dc-lens damaged" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.There is no indication of a product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 16827403
• Report Number: 3012236936-2023-01051
• Device Sequence Number: 12545791
• Product Code: HQL
• UDI-Device Identifier: 05050474731691
• UDI-Public: (01)05050474731691(17)240328
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/19/2023

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: 03/28/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0170
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2021
• 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: Male