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

Model Number	DIU150
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section: a3b, 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 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 upon injecting the preloaded intraocular lens (iol) into the patient's left eye it was noticed that the haptic had not folded and was caught in the plunger as the lens was stuck in the cartridge, and essentially tore from the optic.The issue was noticed when it had unfolded in the patient's eye.The lens was removed and replaced with a same model lens in the same procedure.There was no patient injury.There was no medical/surgical intervention required.From additional information it was learnt that there was no use error.The patient is fine, but there was a little bit of edema noticed during post-op visit.There was no any medical/surgical intervention required to resolve the edema.No other information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 06/06/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveals that it was received with the plunger rod advanced.A haptic could be observed to be stuck in the cartridge and overridden.Viscoelastic residue was distributed through the length of the cartridge.The lens module was inspected and presented with no damage or viscoelastic residue.The device assembly was inspected and presented with no issues.The plunger rod was advanced and no issues were identified.The lens was received cut in half.The lens was torn a the haptic/optic junction and the removed piece included the haptic.Conclusion: the complaint issue trailing haptic not folded was not identified during product evaluation.The other complaint issue iol torn was identified during product evaluation.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 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: 19506946
• Report Number: 3012236936-2024-000161
• Device Sequence Number: 20693354
• Product Code: MJP
• UDI-Device Identifier: 05050474746589
• UDI-Public: (01)05050474746589(17)250916
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 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: 09/16/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U220
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 83 KG