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	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unknown; requested but not provided.Device evaluation: the device was not returned at the manufacturing site, as it was discarded; 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 there were no other complaints 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.Attempts have been made to obtain missing information; however, the account did not provide the information.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 hazy, glare, day driving, and "vaseline smudge" in their left eye (os) with an intraocular lens (iol).The patient is unable to see with the camera or see to edit pictures.Therefore, the lens was explanted.It was reported patient had waxy distance vision.The osi (objective scatter index) was high post-op (generally >3).Patient maintains good j1 near acuity and good quality of vision near.The patient's pre-operative (op) visual acuity was counting fingers (cf) 3 feet 20/20 and post-op uncorrected 20/20 -2 and best corrected visual acuity 20/20.The intended target was -0.24 se (spherical equivalence).There was no vitrectomy, incision enlargement, or sutures required.There was no patient injury.A non-johnson and johnson iol was implanted in the patient's eye.Patient is stated to be very happy post-operation.The iol will not be returned for investigation as it was discarded.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that "g4" field which should have been populated with "no" was inadvertently left blank in the initial mdr report; therefore, the information has been corrected in this supplemental mdr report and the following field has been updated accordingly: section g4: combination product: no.Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: feb 21, 2023.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the suspect lens was received in a plastic insert with plastic wrap.Visual inspection under magnification revealed that the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and further inspected under magnification and no issues were observed.No issues that could cause or contribute to the complaint issues were identified.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: 15602235
• Report Number: 3012236936-2022-02568
• Device Sequence Number: 11345056
• Product Code: MFK
• UDI-Device Identifier: 05050474750517
• UDI-Public: (01)05050474750517(17)241127
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/21/2023

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: 11/27/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU120
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2021
• 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: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White