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

Model Number	DFR00V
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted; give date: not applicable as the intraocular lens (iol) remains implanted.Therefore, lens was not explanted.Device evaluated by mfr: the particle or the device were not returned for evaluation.Therefore, a visual 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.Attempts were made to obtain additional information regarding the complaint; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Doctor reported that while implanting the intraocular lens (iol) he had something stuck to the posterior part of the optic after inserting the iol in the capsular bag.He was not able to remove the particle with the irrigation/aspiration handpiece.It was ultimately removed with forceps.However, the particle was not saved for evaluation.Account indicated that no mark was left on the lens and there was no patient injury.The implant was left in the eye and was clear and centered.No further information was provided.

• 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: 13714467
• Report Number: 3012236936-2022-00586
• Device Sequence Number: 5957589
• Product Code: HQL
• UDI-Device Identifier: 05050474750722
• UDI-Public: (01)05050474750722(17)240330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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: 03/30/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU225
• Was Device Available for Evaluation?: No
• 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: 02/25/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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