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

Model Number	DXW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a5: ethnicity: unknown; when asked, it was indicated "chinese".Section h3-other (81): 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.Attempts were made to obtain the missing information; however, the definite information was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A planned explant of a toric intraocular lens (iol) was reported as the patient complained about their vision.Additional information indicated that the patient complained of having blurry vision and the iol was explanted from the patient's right eye as scheduled on (b)(6) 2023.Another toric lens of different model and diopter (diu150, 12.5 d) was used as a replacement.The patient is stable post-explant and no injury reported.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: oct 16, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the device was returned for evaluation.Product evaluation was performed under magnification.The complaint lens was received cut but not separated.The lens was cleaned and presented with no issues that would have contributed to the complaint event.The complaint issues were not confirmed.The other observed issue during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation, no malfunction or product deficiency was identified, and the reported issue could not be verified.Corrected data: section e1: initial reporter first name: initially customer provided the first name of the doctor to be "james", but additional information provided, also indicated first name of the doctor as "chee".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: 17840401
• Report Number: 3012236936-2023-02459
• Device Sequence Number: 6759182
• Product Code: HQL
• UDI-Device Identifier: 05050474762800
• UDI-Public: (01)05050474762800(17)260507
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/02/2023

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: 05/07/2026
• Device Model Number: DXW150
• Device Catalogue Number: DXW150U115
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2023
• 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: Male
• Patient Weight: 69 KG
• Patient Race: Asian