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

Model Number	DFW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ethnicity/race: unknown/ not provided.It was indicated as "other".Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient developed blurry vision, hence intraocular lens (iol) that was implanted was explanted from the patient's right eye.There was no incision enlargement, vitrectomy or sutures done.Iol was replaced with a different model lens (diu225) but same diopter power size.No patient post-op injury reported.The patient continues to notice blurry vision causing difficulty driving and would like to proceed with iol exchange in the fellow eye.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes returned to manufacturer on: mar.14, 2023 section h3.Device evaluated manufacturer? yes device evaluation: visual inspection revealed that the complaint lens was received cut in half.The lens was cleaned, and no issues that could cause or contribute to the complaint issue could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issues were not confirmed.The other observed issue found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation 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: 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: 16483317
• Report Number: 3012236936-2023-00381
• Device Sequence Number: 12078041
• Product Code: MFK
• UDI-Device Identifier: 05050474751927
• UDI-Public: (01)05050474751927(17)241228
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 12/28/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U235
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/04/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• 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 Sex: Female
• Patient Weight: 68 KG