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); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a3b, a4 and a5: unknown/ asked but not available.If implanted, give date: not applicable, as there is no indication that the lens was implanted section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted section e1:surgeon's name, email address and phone number: unknown/ asked but not available.Section h3: other 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 that the preloaded intraocular lens(iol) was defective.From additional information it was learnt that upon time out and on opening of lens, staff had noticed box of lens was smashed up on one side of box.The lens was opened and was passed off on the field.The doctor had inspected the lens and it was determined to have been torn.The lens was still in one piece but the lens was torn almost in half.So the lens was not inserted and was discarded.Back up lens of the same model ad diopter was used to complete the procedure.No other 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: 20352157
• Report Number: 3012236936-2024-000265
• Device Sequence Number: 7926611
• Product Code: HQL
• UDI-Device Identifier: 05050474731820
• UDI-Public: (01)05050474731820(17)270412
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0230
• 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: 09/10/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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
• Patient Age: 85 YR
• Patient Sex: Male