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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during implantation the dcb00 model intraocular lens (iol), the back haptic broke and there was patient contact with the cartridge tip.There was no incision enlargement, no vitrectomy, and medical attention was not required.It is unknown if sutures were required and unknown if medication was prescribed.Iol directions for use were followed.Patient status post-procedure was reported as temporarily impaired however patient's daily activities are not significantly affected.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted; therefore not explanted.Section h-3 device evaluated by manufacturer: 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 report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 18-jun-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint device was received loose in the original folding carton.The device was inspected under magnification.The complaint device presented with the plunger rod advanced.The lens was stuck in the cartridge and the cartridge tip was damaged in a way consistent with damage that occurred during shipping.The lens module was inspected and presented with no damage or viscoelastic residue.The device assembly was inspected, and no issues were identified.The plunger rod advancement was inspected, and no issues were identified.The lens was removed and presented with a tear to the haptic/optic junction which removed the haptic.The lens was damaged, possibly from removal from the cartridge.The lens also shows lines from being folded.Complaint issue "haptic damaged" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 19567279
• Report Number: 3012236936-2024-000171
• Device Sequence Number: 6948184
• Product Code: HQL
• UDI-Device Identifier: 05050474636057
• UDI-Public: (01)05050474636057(17)261104
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 07/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000185-12
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female