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

Model Number	DIB00
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: unknown as information was not provided.Section a-3a patient sex: unknown as information was not provided.Section a-3b patient gender: unknown as information was not provided.Section a-4 patient weight: unknown as information was not provided.Section a-5 patient ethnicity: unknown as information was not provided.Section a-6 patient race: unknown/asked information was not provided.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the device was not returned 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 report 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
When inserting the preloaded dib00 intraocular lens (iol), it was reported to have been received upside down inside the cartridge.The doctor had to manually correct the lens position and iol was implanted in the patient's eye.The suspect iol is not available for return.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.No further information is available.

• 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: 20839827
• Report Number: 3012236936-2024-000316
• Device Sequence Number: 12787329
• Product Code: HQL
• UDI-Device Identifier: 05050474731738
• UDI-Public: (01)05050474731738(17)270817
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown