MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU225
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a3b,and 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 e1:surgeon's name, 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.Attempts have been made to obtain missing information; 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
It was reported that the preloaded intraocular lens (iol) had resistance while advancing the lens leading to haptic amputation and cracked optic.Tried another lens and the other lens had a giant dent in it.There was patient contact.There was no use error.There was no medical/surgical intervention required.No other information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 10/9/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the suspect product and found the plunger rod was fully advanced and the cartridge and cartridge tip was observed damaged and bent.A haptic was observed to be overridden by the plunger rod which was also bent.Viscoelastic residue was distributed through the length of the cartridge.The plunger tip was observed to be damaged.The lens module was inspected, and no damage or viscoelastic residue was observed.The device assembly was inspected and presented with no issues.No further evaluation was performed.Conclusion: the complaint issue "dc-haptic damaged" was not identified during photo and product evaluation.The observed "dc-haptic detached" is similar to the reported complaint issue (complaint coding may have been the result of the customer being unfamiliar with coding definitions per amo-04-d024).However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Upon further review, the codes were updated from haptic damaged (1069) to haptic detached (1261) and difficult to use (1487).Hence a correction mdr is needed.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.
Additional Manufacturer Narrative
Correction: during record review on 12/31/2024 it was noticed the date in section d9 in supplemental #1 was not correct.The correct date is 10/9/2024.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 20391092
• Report Number: 3012236936-2024-000270
• Device Sequence Number: 6652080
• Product Code: MJP
• UDI-Device Identifier: 05050474746961
• UDI-Public: (01)05050474746961(17)270530
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2025

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: DIU225
• Device Catalogue Number: DIU225U115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 12/31/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/26/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 91 KG