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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight and ethnicity: unknown as information was asked but not provided.Date of event: unknown, not provided, but the best estimate date is between 19-nov-2021 and 27-jan-2022.The device was not returned for analysis therefore, a visual 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.An attempt has been made to obtain missing information; 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 the intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).The iol was explanted in a separate surgical procedure due to blurry portrait view and replaced with a non-johnson & johnson surgical vision lens.No further information is available.
Additional Manufacturer Narrative
Corrected data: additional information was received from the account correcting the patient's affected eye from ocular sinister (left eye) to ocular dexter (right eye).Therefore, this supplemental filing is to correct the incorrect affected eye, ocular sinister (left eye), that was originally reported.Additional information: section a-5 ethnicity: not hispanic/latino section b-3: date of event: 14-dec-2021.Section b-5 describe event or problem: additional information was received confirming there was no patient injury, no medical intervention, and no surgical intervention.Patient outcome post lens exchange is unknown.No further information is available.Product investigation was received, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 18-feb-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut in half and with a detached haptic, which is consistent with a lens that was handled during explant.No issues related to or could have contributed to visual issues were observed.Based on the return condition of the lens, the complaint issue could not be confirmed, and no product deficiency could be identified.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 13434209
• Report Number: 3012236936-2022-00278
• Device Sequence Number: 2251858
• Product Code: HQL
• UDI-Device Identifier: 05050474750685
• UDI-Public: (01)05050474750685(17)240813
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 04/05/2022

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: 08/13/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU205
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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 Ethnicity: Non Hispanic
• Patient Race: White