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

Model Number	DCB00
Medical Device Problem Codes	Mechanical Jam (2983); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a3b, a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section e1:surgeon's email address and phone number: unknown/ asked but not available.Section h3: 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 plunger of the preloaded intraocular lens (iol) was difficult to advance and once advanced the lens was observed to be scratched.The lens was removed from the patient's right eye and replaced with the back up lens of the same model and diopter in the same procedure.From additional information it was learnt that the issue was noticed during implantation and application.No other information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 12/18/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the suspect product and found the plunger rod was completely advanced with viscoelastic residue observed distributed through the length of the cartridge.The cartridge tip showed stress marks; however, the stress marks were in specification for a used device.Additionally, the plunger rod tip was bent in a way consistent with damage that may have occurred during shipping.The lens module was inspected and presented with no damage however viscoelastic residue was identified in the lens module which could indicate an excessive amount was used and could have contributed to the complaint event.The lack of damage in the lens module indicates that the plunger rod tip damage likely occurred after lens advancement.The device assembly was inspected and presented with no issues.The plunger rod advancement was inspected and presented with no issues.No lens was received for evaluation.Conclusion: the complaint issue "stuck in cartridge" and "cosmetic issue" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.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 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: 20837432
• Report Number: 3012236936-2024-000317
• Device Sequence Number: 8627581
• Product Code: HQL
• UDI-Device Identifier: 05050474636163
• UDI-Public: (01)05050474636163(17)270122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: DCB00
• Device Catalogue Number: DCB0000240
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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 Age: 65 YR
• Patient Sex: Female