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 Code	Visual Impairment (2138)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was explanted from patient's right eye due to power surprise, marked deviation from measured target observed first during post-op exam.The lens was explanted and replaced with dxr00vu140 in secondary procedure.Additional information indicated that there was no patient injury, daily activities of the patient were not affected.There was incision enlargement and sutures were required.The intended/targeted post-operative refraction (for initial implant) was :-0.50.No other information is available.
Additional Manufacturer Narrative
Section h3: other 81: the device was not returned for evaluation as the lens remain implanted in the eye.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, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 02/05/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint lens reveal that it was cut in half with both haptics detached, consistent with a lens that was cut and explanted.One lens haptic was missing.The lens was further inspected, and no issues were observed that could cause or contribute to the complaint issue.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in initial report, event date was mentioned as 12/15/2023.However, the correct event date is 11/15/2023.Also, product evaluation results provided in the 1st follow up report submitted in section h10 text was indicated incorrectly.It should have been noted as "the lens was further inspected and no issues that could cause or contribute to the complaint issue was observed.The complaint issue "explant" and "unexpected postop refraction" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction".Field below is updated accordingly: section b3: date of event: 11/15/2023.Additional information: and upon further review information received from additional information that the visual acuity results were updated.The pre-op best corrected visual acuity is 20/20.The post-op (post-initial implant) best corrected visual acuity is 20/20, the post-op (post-replacement implant) best corrected visual acuity, is 20/20.Also, in first follow up report, section h2: follow up type was missed to mention as "additional information" and "device evaluation".Section h3: device evaluated by manufacturer was missed to mention as '"yes".Fields below updated accordingly: section h2: correction, additional information, device evaluation: boxes checked.Section h3: device evaluated by manufacturer: box checked.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 18507959
• Report Number: 3012236936-2024-00095
• Device Sequence Number: 18118083
• Product Code: HQL
• UDI-Device Identifier: 05050474765252
• UDI-Public: (01)05050474765252(17)260201
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: DXW300
• Device Catalogue Number: DXW300U160
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 03/14/2024; 04/25/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 04/09/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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 Age: 29 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White