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

Model Number	ZCU300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: information unknown/not provided.Date of event: the exact date of event is unknown, not provided, but the best estimate date is (b)(6) 2021.If explanted, give date: not applicable as the device remains implanted.Manufacturer telephone number: (b)(4).The intraocular lens (iol) is not returning for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A doctor reported that a post-lasik patient was implanted with an intraocular lens (iol) in the left eye of model zcu300 on (b)(6) 2020.That the patient is now showing even more cylinder in the same axis.Maximum preop ks (keratometry) were shown by iol master 700 to be around 2.1 axis 155.Manual and topographer ks showed less, around 1d.Ora (ocular response analyzer) showed variable, between 2 and 2.2, same axis.It was indicated that the patient wanted good near uncorrected.Post op refraction has consistently been around -2.50 + 2.50 x 155.The current lens position looks to be around axis 135.The doctor noted that he did run multiple scenarios on astigmatism fix, and he has made repeated post-op measurements.The iol master now says 3.03d of cylinder, axis 155.Manual and topo are not different from pre-op.That just rotating the lens to the indicated axis (a small amount) leaves more than 2d of cylinder in the same axis; hence, the doctor determined that he needs to exchange the iol with at least a zcu450.The patient was scheduled to come in on (b)(6) 2021.No further information was provided.
Additional Manufacturer Narrative
Additional information: supplemental report is required as the lens has been returned which means the lens was explanted.The explant date (date of surgery) of the device was reported to be (b)(6) 2021.The following field was updated accordingly: section d6.If explanted, give date: (b)(6) 2021.Section d9.Device available for evaluation? yes.Returned to manufacturer on: 3/4/2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut in half, which is consistent with a lens that was removed.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 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.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the code(s) 4582 provided on the initial mdr report needs to be removed as it should not have been indicated in the initial report.Also, the health effect - clinical code 2330 should have been entered in section h6 of the initial mdr report.In review, it was also noticed that the health effect - impact code 4629 was inadvertently not entered in the follow-up #1 mdr report after it was learned that the lens had been explanted; therefore, the information has been captured in this supplemental mdr report.Fields below updated: all pertinent information available to johnson and 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 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; van swietenlaan 5; groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 11303014
• Report Number: 9614546-2021-07061
• Device Sequence Number: 17392580
• Product Code: HQL
• UDI-Device Identifier: 05050474660151
• UDI-Public: (01)05050474660151(17)241206
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2024
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 03/04/2021; 08/31/2022
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/31/2021; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2019
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Female