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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Race: unknown/ asked but not available.The device was not returned 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.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was explanted from the left eye as patient complained of halos at night and blurry distance vision.Another competitor lens of smaller diopter (26.5d) was used as the replacement iol.There was no other injury reported.No other intervention was required.The patient was doing good post operation.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: may 6, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the lens was received cut in half.The lens was cleaned and, no issues that could contribute to visual disturbances or issues could be identified.Based on the return condition of the lens, no further product evaluation could be performed.Conclusion: the reported complaint issues were not confirmed.Therefore, there is no indication of a product deficiency or product malfunction.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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14378849
• Report Number: 3012236936-2022-01257
• Device Sequence Number: 5150101
• Product Code: HQL
• UDI-Device Identifier: 05050474750814
• UDI-Public: (01)05050474750814(17)240328
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU270
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2021
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic