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

Model Number	PCB00
Medical Device Problem Codes	Inaccurate Delivery (2339); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight and ethnicity: information unknown/ not provided.Implant date: does not apply.Lens was not implanted.Explant date: does not apply.Lens was not implanted.Therefore, not explanted.Initial reporter telephone number: (b)(6).Initial reporter first/given name: not provided.The intraocular lens (iol) has not been returned for evaluation.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
On (b)(6) 2021, the customer filled the injector with healon and pushed it out to the first mark shortly before the implantation according to normal procedure.Then it was found that the plunger did not engage.The thread did not grip and the lens slid out of the injector in an uncontrolled fashion.The customer indicated that there was no patient injury.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - returned to manufacturer? yes.Section d9 - date evaluated by manufacturer: 6th january 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed the complaint lens stuck inside the cartridge of the handpiece.The handpiece was disassembled and no defects or assembly issues were observed; the plunger rod was observed in the advanced position.The lens was removed and observed with lens damage and a detached haptic.Excessive viscoelastic residue was observed inside the cartridge which suggests an excessive amount of ophthalmic viscosurgical device (ovd) was used during loading and insertion which can contribute to deployment issues.The complaint issue could not be confirmed, however it cannot be confirmed to be related to manufacturing (refer to previous statement regarding excessive ovd usage) and no product deficiency could be identified.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional/similar (as applicable) complaints for this order number have been received.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12544729
• Report Number: 2020664-2021-07476
• Device Sequence Number: 4102930
• Product Code: HQL
• UDI-Device Identifier: 05050474558335
• UDI-Public: (01)05050474558335(17)240211
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 02/11/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• 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: 09/02/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown