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

Model Number	ZCU150
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight and ethnicity: unknown/ not provided.If explanted, give date: not applicable, as lens remains implanted.Mfr: telephone number: (b)(4).The device is not returning for evaluation as remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending 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
It was reported that an intraocular lens (iol) implanted in the left eye (os) rotated.Visual acuity (va): 20/70 os, best corrected visual acuity (bcva): 20/25 os.Patient would like to proceed with iol rotation os.May need to have malyugin ring for good dilation.Toric iol rotation from 93 to about 25-30 degree (poor dilation so estimated axis).Reposition occurred, vitrectomy and sutures performed.No other information provided.
Additional Manufacturer Narrative
Corrected data and additional information: upon further review it was found that codes for sections h6: type of investigation code 4117, h6: investigation findings code 3221, were inadvertently not provided.Additionally, the conclusion code 11 was mistakenly provided in the initial report.The appropriate conclusion code is 67.The appropriate codes have therefore now been provided in this submission.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 9728 NX; NL 9728 NX
• MDR Report Key: 11168696
• Report Number: 9614546-2021-07018
• Device Sequence Number: 3532729
• Product Code: HQL
• UDI-Device Identifier: 05050474657854
• UDI-Public: (01)05050474657854(17)250226
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U230
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/09/2021
• 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