MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. 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	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: pt info: unknown, as information was asked but not provided.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.An attempt was made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the pre-loaded intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye) on (b)(6) 2021.The iol was explanted during a secondary surgical procedure on (b)(6) 2021 due to halo and vision issues observed during post-op exam.It was reported the patient is temporarily impaired.There was no incision enlargement and no vitrectomy.Through follow-up, additional information was received stating it is unknown if the patient was still temporarily impaired after dfr00v 19.5 iol exchange.Iol replacement information is also unknown, but the explanted iol was sent back to jjsv in the replacement lens box.Patient outcome post-lens exchange is also unknown.No further information is available.
Additional Manufacturer Narrative
Additional information received with product return: dfr00v iol was replaced with dib00 19.5 diopter iol.Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 13-jul-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could contribute to visual disturbances could be identified.Based on the return condition of the lens, no further product evaluation could be performed.Complaint issue ¿halo vision¿ and ¿blurry vision¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: additional information was received updating original device explant date of 07-dec-2021 which was incorrect.Correct explant date was (b)(6), 2022.Field below updated to reflect this.Section d-6b if explanted, give date: (b)(6)2022.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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15023414
• Report Number: 3012236936-2022-01801
• Device Sequence Number: 6800823
• Product Code: HQL
• UDI-Device Identifier: 05050474750661
• UDI-Public: (01)05050474750661(17)240810
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 08/22/2022

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: 08/10/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU195
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 08/18/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/16/2022; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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 Sex: Unknown