MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	DFR00V
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age and weight: unknown, information not provided.If explanted, give date: not applicable, as the lens remains implanted.Device evaluation is anticipated to be performed on the preloaded device.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was loaded properly; however, the plunger had resistance when advancing.After the insertion of lens into patient's right eye, it was observed on unfolding that the optic was scratched and the scratch was outside the visual axis.The lens remains implanted and patient has not experienced any visual disturbance.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: nov 12, 2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.No complaint lens was received as it remains implanted, and therefore no lens evaluation could be performed on the lens.Visual inspection under magnification, of the simplicity inserter, revealed viscoelastic residue inside of the cartridge.The external assembly was inspected and no issues were identified.The handpiece was disassembled and the assembly was inspected, presenting with no assembly issues.Further inspection revealed that the cartridge tip was damaged.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional investigation request (ir) for this production order number has 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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12677958
• Report Number: 2020664-2021-07792
• Device Sequence Number: 4531239
• Product Code: HQL
• UDI-Device Identifier: 05050474750661
• UDI-Public: (01)05050474750661(17)240527
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 05/27/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White