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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a preloaded intraocular lens (iol) was damaged.Issue was observed upon opening the packaging.Despite several follow ups no additional information was provided.This is report 1 of 3.
Additional Manufacturer Narrative
Not applicable, as there was no patient contact with the product.If implanted, give date: not applicable, no patient contact with the product.If explanted, give date: not applicable, no patient contact with the product.Telephone number: +011(44)1509564319.The intraocular lens (iol) 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.Attempts were made to obtain additional information regarding the complaint.However; to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 8th july 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the handpiece was received with the lens inside of the cartridge and overridden by the plunger rod.The lead haptic of the iol was also observed to be unfolded.The handpiece was disassembled and the assembly was inspected, no assembly issues that could contribute to the observed issues could be identified.The iol was removed from the cartridge and cleaned, revealing that the lens was damaged, in a way consistent with a lens that was overridden the plunger rod.The complaint issue 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.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 14246403
• Report Number: 3012236936-2022-01143
• Device Sequence Number: 4446051
• Product Code: HQL
• UDI-Device Identifier: 05050474558342
• UDI-Public: (01)05050474558342(17)240510
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 05/10/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000240
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 09/25/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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: Unknown