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

Model Number	DXR00V
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
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: 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 explanted from patient's eye.Additional information was received and it was learnt that there was some issue with the haptic and the lens was explanted.Reportedly the lens was stuck in injector during implantation.The lens was fully inserted, removed and replaced with a same model and same diopter lens.There was no use error.There was no patient injury.Sutures were used.The patient's vision has improved.There were no daily activities affected.No other information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 06/20/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the suspect product and found the cartridge and cartridge tip were damaged.Viscoelastic residue was distributed through the entire length of the cartridge.The lens module was inspected and presented with no damage, indicating the plunger rod advanced properly, or viscoelastic residue.The device assembly was inspected and presented with no issues.The plunger rod advancement was inspected, and no resistance was felt however the plunger rod tip was bent.The lens was removed from the paint and presented with damage to the optic body and a torn with a piece missing.A haptic also presented with damage.No further evaluation was performed.Conclusion: the complaint issue haptic damaged was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 19566906
• Report Number: 3012236936-2024-000166
• Device Sequence Number: 6112206
• Product Code: POE
• UDI-Device Identifier: 05050474761766
• UDI-Public: (01)05050474761766(17)250423
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/15/2024

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: 04/23/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU185
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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: 75 YR
• Patient Sex: Male