MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU300
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Visual Impairment (2138); Discomfort (2330)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The account reported of a very big post-op surprise on the right eye of a patient that was implanted with an intraocular lens (iol).The patient is a is post myopic (rk) radial keratotomy (8-cuts) who was implanted based on barret post rk formula targeting +0.12.3-weeks post-op manifest refraction (mrx) +3.25 sphere (sph) 20/20.The patient was very unhappy and wanted to have corrective surgery as soon as possible.The doctor was concern about the power of the lens.The date that the unexpected pos-op refraction issue first noticed was indicated to be on (b)(6) 2021; also confirmed on (b)(6) 2021.The iol was explanted in a secondary surgical procedure on (b)(6) 2021 as scheduled.The surgery was completed successfully using a replacement lens, model diu375, 27.5 diopter positioned at 040.There were no medical or surgical interventions required.There was no patient injury reported and patient outcome post-operative day-1 (pod1), uncorrected visual acuity (ucva) was reported to be 20/20-2.No further information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was realized that the event should not have been reported since the patient with post refractive procedure rk (radial keratotomy) would require a different lens power to be calculated/used.In this case, the patient was initially implanted with a 23.5 diopter lens which was then exchanged for a 27.5 diopter.The iol replacement resulted in an ucva (uncorrected visual acuity) of 20/20-2.There were calculation issues with the lens implanted initially and the reported event was not due to the lens product problem or malfunction.Therefore, the event is no longer reportable and no further information will be provided under this manufacturer report number 2020664-2021-07830.Additional information: section h3-other (81): the intraocular lens (iol) has not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12670314
• Report Number: 2020664-2021-07830
• Device Sequence Number: 4531235
• Product Code: HQL
• UDI-Device Identifier: 05050474660229
• UDI-Public: (01)05050474660229(17)250306
• 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: 2021
• Device Explanted Year: 2021
• 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): 01/11/2022

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: 03/06/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U235
• Was Device Available for Evaluation?: No
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2020
• 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: Male
• Patient Weight: 79 KG
• Patient Race: White