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

Model Number	DIU150
Medical Device Problem Codes	Break (1069); Crack (1135); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by doctor that another doctor had a similar experience where the cartridge was splintered during delivery of the iol, but because this doctor had shared his experience from last week with her, she didn't inject the intraocular lens (iol) into the eye, and while there was increased resistance with the back up delivery system, she was able to inject the back up iol without incident.Additional information from the doctor who operated this case stated that the this is the first time this has happened to her.On the second lens she asked the scrub to overfill the cartridge with provisc.That lens went in fine, but it might have been fine either way.This happened with a eyhance toric.It appears either the lens was stuck from a manufacturing error, or something else.But as the plunger was going down the lens/cartridge it was obvious the lens was getting damaged by the plunger and then the cartridge cracked in the meantime.Since the other doctor had told her about what happened to him last week, she quickly realized the same thing was happening and pulled it out of the eye before being injected and needing to be cut.Further follow up stated that only the cartridge tip made contact with the eye.The procedure completed successfully using same model backup lens.There was no use error.No patient injury and no medical/ surgical intervention required.No further information was provided.A separate report has been submitted for the event described by the first doctor.
Additional Manufacturer Narrative
Section a2: age/date of birth: unknown, information not provided.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: 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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 9/21/2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint device was received with the plunger rod advanced to the cartridge tip.The complaint cartridge revealed that the cartridge tip was cracked and damaged.The cartridge could also be observed to be damaged.Further inspection of the cartridge revealed that there was not viscoelastic residue dispersed throughout the cartridge, suggesting that an inadequate amount of ovd/bss may have contributed to the complaint issue.The lens module was inspected, no viscoelastic residue and no marks could be identified that would indicate that the plunger rod advanced incorrectly.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.No iol was received as part of this return.Conclusion: the complaint issues lens damaged and stuck in cartridge were not confirmed during product evaluation.The observed issue cartridge tip cracked/damaged is similar to the complaint issue cartridge crack and could not be confirmed to be related to the manufacturing or design process.As per 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.

• 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: 17814778
• Report Number: 3012236936-2023-02423
• Device Sequence Number: 6205312
• Product Code: MJP
• UDI-Device Identifier: 05050474746619
• UDI-Public: (01)05050474746619(17)241004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/07/2023

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: 10/04/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U235
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White