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

Model Number	DXW150
Medical Device Problem Codes	Break (1069); Component Missing (2306); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 and complaint history for production order 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 were made to obtain the missing information; however, no additional information 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 toric intraocular lens (iol) was opened during surgery and was found to be defective, as the injector went above the lens instead of progressing the lens.Through follow-up, it was learned that the cartridge tip was inserted into the eye wound and the lens would not advance.When the surgeon saw this, it was also noticed that the lens was cracked in several places, so the surgeon withdrew the cartridge from the eye.There was no patient injury; the surgeon withdrew the cartridge to prevent injury to the patient¿s eye.No medical or surgical intervention was required.Through additional follow-up, it was learned that the procedure was completed successfully using a back-up lens (same model and same diopter) for the left eye.There were no complications and the patient is stable.It was reported that no cartridge lubrication was used.The dwell time was 3 minutes or less.When advancing the lens the scrub technician made small 1/4 twists.It was noted from the scrub technicians who were in the surgery that "there were no printed instructions on proper procedures for loading and filling the chamber of the cartridge, nor what to fill the chamber of the cartridge with." no further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 22, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection of the handpiece found the handpiece was fully advanced, the lens was stuck in the cartridge, and there was an insufficient amount of ophthalmic viscosurgical device (ovd).The cartridge tip was observed to be bent as well.The lens was unable to be removed from the cartridge; therefore, visual inspection could not be performed on the lens.No further issues were identified.The complaint issue "lens damaged", "delivery issue", and "missing component" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 18495431
• Report Number: 3012236936-2024-00078
• Device Sequence Number: 7188023
• Product Code: HQL
• UDI-Device Identifier: 05050474762992
• UDI-Public: (01)05050474762992(17)260625
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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 Expiration Date: 06/25/2026
• Device Model Number: DXW150
• Device Catalogue Number: DXW150U210
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2023
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White