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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information unknown/ not provided.Asku.Device evaluation: the complaint lens was received wrapped in gauze.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, no issues that could contribute to or cause the complaint issue could be identified.Manufacturing record review: the manufacturing records review was performed, and no nonconformity report was found as part of this manufacturing records review.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints were received for this production order number.Conclusion: the complaint issues were not identified during product evaluation.Therefore, there is no indication of a product deficiency or product malfunction.An attempt was made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to mechanical failure which was diagnosed on (b)(6) 2022.Further information noted that the mechanical failure was described as patient had blurry vision, unable to read or see clearly.Explanted iol was replaced with aab00 +22.5 diopter size iol.There was new incision made and the lens was removed whole, but no vitrectomy and no sutures performed.There was no patient post-op injury.No other information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 16308736
• Report Number: 3012236936-2023-00131
• Device Sequence Number: 6792033
• Product Code: MFK
• UDI-Device Identifier: 05050474750708
• UDI-Public: (01)05050474750708(17)241004
• 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
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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: 10/04/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• 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: 01/11/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC VISCOELASTIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female