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)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported lens defective.Through follow-up it was confirmed that during the preparation of the injector to implant the lens, there has been a problem that appears to have damaged the lens; it has been confirmed that there has not been patient's contact.No further information has been provided.
Additional Manufacturer Narrative
Date of event: unknown / not provided.If implanted, give date: lens was not implanted.If explanted, give date: lens was not implanted, therefore not explanted.(b)(6).The device is not received; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/ lot history record and complaint trending 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.Date returned to manufacturer: jan.8, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: the complaint lens was observed stuck in the cartridge to the handpiece.The plunger rod was observed in the locked and advanced position and no defects or assembly issues were observed before and after disassembling the handpiece for inspection.The lens was removed and two damaged and torn pieces of lens from the optic body with the haptics intact were observed (not detached haptics); the rest of the lens was not returned.Excessive viscoelastic residue was observed throughout the handpiece which suggests excess ophthalmo viscosurgical device (ovd) was used during loading and deployment, which could contribute to deployment issues and consequently the complaint issue (the staged position of the lens may get compromised by the excessive ovd causing the plunger rod to contact the lens in an unintended manner).The complaint issue was confirmed, however this cannot be confirmed to be related to manufacturing and no product deficiency could be identified.Manufacturing records review the manufacturing records review for this production order shows that the units were released within specification.A search revealed that no other complaints were received from this production order.Conclusion:.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 12857551
• Report Number: 3012236936-2021-00025
• Device Sequence Number: 20079208
• Product Code: HQL
• UDI-Device Identifier: 05050474558274
• UDI-Public: (01)05050474558274(17)240420
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 04/20/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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