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 Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight and ethnicity: information unknown/not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the patient has bilateral implants.A synergy intraocular lens (iol) in the left (os) eye and a non-johnson & johnson lens (panoptix) in the right (od) eye.The patient complained of halos with oncoming traffic, poor vision, and blurry vision in the left eye.Patient also stated that the left eye has more rings than the right eye and glows larger in the left eye.Patient is "more sensitive" to glare in the left eye.Since the patient was happy with the panotix lens, the lens in the left eye was explanted and the patient is happy with the panoptix, non-johnson & johnson replacement lens.There was no patient injury, no vitrectomy, and the patient left surgery without complications.No further information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes returned to manufacturer on: mar.25, 2022.Section h3.Device evaluated manufacturer? yes device evaluation: visual inspection under magnification revealed that the lens was cut in half.The lens was cleaned, and no further issues were observed.No issues related to or could have contributed to visual issues were observed.Based on the returned condition of the lens (cut in half) no further product evaluation could be performed.The complaint issue reported could not be confirmed and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.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.

• 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: 13905134
• Report Number: 3012236936-2022-00747
• Device Sequence Number: 11860054
• Product Code: HQL
• UDI-Device Identifier: 05050474750739
• UDI-Public: (01)05050474750739(17)240819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/24/2022

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: 08/19/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU230
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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: 49 YR
• Patient Sex: Male
• Patient Race: White