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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the device was not returned at the manufacturing site, reason unknown; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation was required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient was experiencing strobe lights, starbursts, and glare at night in their left eye (os) resulting in the need to explant the intra-ocular lens (iol).The replacement iol is of a different model and diopter.There was no reported patient injury and no issues are reported with the patient post-operation.No additional information was reported.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the health effect - clinical code (1864) was inadvertently not entered in the initial mdr report.Therefore, the information has been captured in this supplemental mdr report and the following field was updated accordingly: section h6: health effect - clinical code: 1864 - flashers.Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 10/7/2022 device evaluation: the complaint lens was received inside of a specimen cup.Visual inspection under magnification revealed that the complaint lens was received cut into five pieces (one missing) and with a detached haptic.The pieces of the lens were cleaned and, no issues that could contribute to or cause glare or visual disturbances could be identified.Based on the return condition of the lens, no further product evaluation can be performed.As a result of the investigation there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15452221
• Report Number: 3012236936-2022-02371
• Device Sequence Number: 20551537
• Product Code: MFK
• UDI-Device Identifier: 05050474750678
• UDI-Public: (01)05050474750678(17)240812
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/03/2022

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: 08/12/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU200
• 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: 08/29/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White