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	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient's operative eye in a secondary surgical procedure.No further information was provided.
Additional Manufacturer Narrative
Age, weight and ethnicity : unknown/ asked but information has not been provided.Date of event: the exact date is unknown, the best estimate is prior to (b)(6) 2022.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: unknown, as the serial number was not provided.If implanted, give date: unknown, information not provided.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.As the serial number of the device is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.Attempts have been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received which indicated that the serial number of the involved device was 8133442116; therefore, the following fields were updated accordingly: section d4: serial number: (b)(6).Section d4: expiration date: apr 23, 2024.Section d4: udi number: (b)(4).Section h4: device manufacture date: apr 23, 2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section h3: device evaluated by manufacturer: yes.Device evaluation: the suspect iol was received wrapped in foam inside of a specimen cup and a product declaration shipping form.The suspect iol was received cut in half, with only one half received.The half was cleaned and visual inspection under magnification revealed no issues that could contribute to or cause the complaint issue.Based on the return condition of the lens, no further product evaluation could be performed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.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: 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: 15993010
• Report Number: 3012236936-2022-03102
• Device Sequence Number: 6089726
• Product Code: MFK
• UDI-Device Identifier: 05050474750654
• UDI-Public: (01)05050474750654(17)240423
• 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 Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 03/08/2023

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: 04/23/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU190
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 01/06/2023; 02/10/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/31/2023; 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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