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

Model Number	DXW300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Discomfort (2330)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5: unknown/ not provided.Asku.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 have been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a toric intraocular lens (iol) was explanted from the patient's left eye, due to patient neuroadaptation issues/ patient unhappy with outcome.Visual acuity pre-op - 20/50, visual acuity post-op - 20/50.Suspect iol was replaced with another toric lens of different model and diopter (zcu300, 17.5d).There was no incision enlargement, no vitrectomy and no sutures performed.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: (b)(6) 2023.Section h3.Device evaluated 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 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 issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: new information received that email address of physician reporter was incorrectly provided in the initial report submitted.Correct email address is (b)(6).The field below update to correct this.Section e1: email address: (b)(6).Additional information: new information received that patient is white and not hispanic.Specific visual issue was that patient stated that ¿things looked out of alignment¿.Visual issue was resolved with the replacement iol.This report is being submitted to add the new information received.The fields below are being updated: section a5: race and ethnicity: white and not hispanic.Section h6: health effect clinical code: 2137 ( to capture report of 'things looked out of alignment" - blurry).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: 17818631
• Report Number: 3012236936-2023-02394
• Device Sequence Number: 6138085
• Product Code: HQL
• UDI-Device Identifier: 05050474765290
• UDI-Public: (01)05050474765290(17)250613
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/30/2023

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: 06/13/2025
• Device Model Number: DXW300
• Device Catalogue Number: DXW300U180
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 10/27/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/11/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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 Ethnicity: Non Hispanic
• Patient Race: White