MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown, not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis symfony intraocular lens (iol) was explanted from the patient's right (od) eye because the patient complained of having blurry vision one week after the implant.The patient also reported cloudiness, shadows, and double vision.Bscva (best spectacle corrected visual acuity) was 20/40 + 2 before and after was 20/20.The customer noted that the patient seems happy at one-day post-operation.No further information provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: return to manufacturer: 2/26/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during the explant.The lens was cleaned and no cosmetic defects were observed.The complaint issue could not be confirmed and no product deficiency was identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product 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: upon further review it was noted that returned product investigation results provided in follow-up #1 comment in section h10 text, was for another file.This supplemental mdr is being submitted to correct the information provided on product investigation results.Note that section h6 investigation codes provided in follow-up #1 mdr remain the same.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens no further product evaluation could be performed.The complaint issue could not be confirmed and no product deficiency was identified.Conclusion: as a result of the investigation, there is no indication of a quality product 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: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11408625
• Report Number: 9614546-2021-07089
• Device Sequence Number: 3243678
• Product Code: POE
• UDI-Device Identifier: 05050474605220
• UDI-Public: (01)05050474605220(17)240308
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 03/08/2024
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/18/2021; 05/14/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/13/2021; 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention