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

Model Number	DXW225
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown, information was requested but not provided.Section b3: date of event: exact date is unknown/not provided.Best estimate date is on or prior to (b)(6) 2023.Section d6a: if implanted; give date: unknown/information not provided.Section d6b: if explanted, give date: not applicable as the device remains implanted.Section h3-other (81): the device was not returned for evaluation as the lens remains implanted; 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.Section h6: health effect - clinical code: 4581 - this code was used for the reported lens dislocation.Attempts have been made to obtain additional information regarding the event; however, to date, the information has not been received.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 scheduled to be explanted and replaced with another johnson and johnson lens, model ar40, 8.5 diopter due to post operative anterior extension and decentration.No further information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that although they were explained in h10 text section, these fields have been missed in their specific sections the1st supplemental report submitted.Section d6b: if explanted, give date: (b)(6) 2023 and section h1: type of reportable event: serious injury.This 2nd supplemental report is submitted to correct these sections.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received which the following fields were updated accordingly: section b5: the original lens was implanted on (b)(6)2023.This lens was explanted from the patient's right eye (od) on (b)(6)2023.The replacement lens was a ar40e, 8.5 diopter.A vitrectomy was performed but the customer did not know if there was a capsule tear or not.The customer did not have the patient outcome.The lens was discarded.Section a2: age: 72 years section a3: gender: female section b1: report type: adverse event section b2: outcomes attributed to adverse event: required intervention to prevent permanent impairment/damage (devices) section d6a: if implanted, give date: (b)(6)2023 section d6b: if explanted, give date: (b)(6)2023 section h1: type of reportable event: serious injury section h6 health effect-impact code : 4625 - additional surgery (unplanned vitrectomy) section h6: type of investigation: 4115 - device discarded corrected data: the following codes used in the initial mdr report are no longer applicable to this event: section h6: health effect - impact code: 2199 - no health consequences or impact section h6: type of investigation: 4114 - device not returned 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: 18387704
• Report Number: 3012236936-2023-03273
• Device Sequence Number: 4209844
• Product Code: HQL
• UDI-Device Identifier: 05050474763920
• UDI-Public: (01)05050474763920(17)250401
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U085
• Was Device Available for Evaluation?: No
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 02/06/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/29/2024; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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 Age: 72 YR
• Patient Sex: Female