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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that preloaded intraocular lens (iol) with model pcb00 was damaged during lens preparation process.When a surgeon advanced the plunger, it was not pushed by the plunger enough and iol got stuck inside the cartridge.They used other manufacturer lens to complete the surgery since the iol haptic was partially damaged.No further information available.
Additional Manufacturer Narrative
Patient information cannot be provided due to personal data privacy legislation/policy.Section d6a: implant date: not applicable, as lens was not implanted.Section d6b: explant date: not applicable, as lens was not implanted.Therefore, lens was not explanted.Section e1: initial reporter telephone number: (b)(6).Section h3-other (81): it was indicated that the device is not returning 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
Section d9: device available for evaluation: yes.Date returned to manufacturer: 09 oct 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod in the advanced and locked position.The complaint cartridge was received with viscoelastic residue dispersed throughout the length of the cartridge.No issues with the cartridge that could cause or contribute to the complaint issues could be identified.The lower body assembly was inspected, no marks in the body could be observed that would indicate that the plunger rod did not advance properly.Viscoelastic residue could be identified inside of the lower body, suggesting that an excessive amount of ovd/bss may have contributed to the complaint issue could be identified.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be observed.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & 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: 17889986
• Report Number: 3012236936-2023-02436
• Device Sequence Number: 6966569
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)251102
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 11/02/2025
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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
• Patient Sex: Unknown