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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a5: unknown/ asked but not available.Section d6a: 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 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 preloaded intraocular lens (iol) had a defect in it near the nozzle, so when advancing the lens down the cartridge the plastic started to bulge out and the lens began to unfold slightly through the opening on the side of the cartridge.The injector did come into contact with the patient.Another johnson & johnson lens was implanted without incident.There was no delay in procedure.The device was discarded.No further information was provided.
Additional Manufacturer Narrative
Correction and additional information: upon further review, the cartridge issue reported in the initial report was reassessed as cartridge damage instead of cartridge tip damage and is considered not reportable because it was reported as "lens began to unfold slightly through the opening on the side of the cartridge".Also, product was not received and provided photo evaluation did not identify cartridge tip crack/damage.Therefore, this follow-up #1 is being submitted to provide the corrected data.There will no longer be any further reporting under mfr report number 3012236936-2025-0000283.The following sections have been updated accordingly: section d9: device available for evaluation: product was not returned, but photograph was provided.Section d9: returned to manufacturer on: not applicable.Section h3: device evaluated by manufacturer: product was not evaluated as it was not returned, but photograph was evaluated.Device evaluation: no suspect product was received; however, photos were provided by the customer.The customer provided phots were evaluated.The photo displays the suspect product and the cartridge could be observed to be damaged and cracked.Since no product has been received no further evaluation was performed.Conclusion: the complaint issue "cartridge tip cracked/damaged" was not identified during photo evaluation.The observed "cartridge damaged" and "cartridge crack" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue 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.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.Section h6: device code: updated as "1069 - break" instead of "1135 - crack".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: 21284927
• Report Number: 3012236936-2025-000028
• Device Sequence Number: 15430821
• Product Code: HQL
• UDI-Device Identifier: 05050474731738
• UDI-Public: (01)05050474731738(17)270815
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/28/2025

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: DIB00
• Device Catalogue Number: DIB00U0190
• Was Device Available for Evaluation?: No
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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: 79 YR
• Patient Sex: Male