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	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, ethnicity: information unknown/ not provided.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted so not explanted.Telephone number: (b)(6).The intraocular lens (iol) has not been received.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded product intraocular lens (iol) was broken in the injector during the procedure.No additional information was provided.
Additional Manufacturer Narrative
Section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 2nd february 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned for evaluation.The complaint issue (dc-lens damaged) could not be confirmed, and no product deficiency could be identified.No issues related to lens damage was observed with the lens.Additional conditions were observed with the returned product (stuck in cartridge, override and cartridge tip cracked/damaged), but they could not be confirmed to be related to the manufacturing/design process.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: 12980015
• Report Number: 3012236936-2021-00097
• Device Sequence Number: 17340918
• Product Code: HQL
• UDI-Device Identifier: 05050474558397
• UDI-Public: (01)05050474558397(17)221112
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 11/12/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000265
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2019
• 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