MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; TORIC IOLS

Model Number	ZCT400
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a toric intraocular lens (model zct400, +25.5 diopters) was implanted in the eye of a male patient.Reportedly, together with the implantation of the intraocular lens (iol), a dsaek surgery (descemets stripping automated endothelial keratoplasty) was performed.There was no trauma or injury to the patient's eye after the procedure.After the cornea transplant had cleared, it was noticed that iol had rotated and the axis was off.Also the spherical power was noticed to be off.The surgeon had used the ora (ocular response analyser) and had verified the proper axis orientation.The iol was then explanted and replaced, without complications, with another lens, same model smaller diopter +23.5.No incision enlargement, no vitrectomy was performed.One corneal suture was used at the main wound.Post-op one day after iol exchange, uncorrected va (visual acuity) improved to 20/40 from 20/200.Additional information was received and the patient was reported doing great and happy.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6642592
• Report Number: 9614546-2017-00535
• Device Sequence Number: 16356004
• Product Code: HQL
• UDI-Device Identifier: 05050474554023
• UDI-Public: (01)05050474554023(17)190113
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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: Physician
• Device Expiration Date: 01/13/2019
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/31/2017
• 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