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

Model Number	ZCT450
Medical Device Problem Codes	Off-Label Use (1494); Scratched Material (3020)
Health Effect - Clinical Codes	Corneal Edema (1791); No Code Available (3191)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: unknown, not provided.Sex/gender: unknown, not provided.If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.Initial reporter: a contact name was not provided.(b)(4).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) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states that only insertion instruments that have been validated and approved for use with this lens should be used.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.
Event or Problem Description
It was reported that an intraocular lens (iol) was inserted into the patient's eye using a non-amo injector/cartridge.The lens was torn, so it had to be removed and replaced.Reportedly, the exchange did not go well, as the cutting tools (unknown models) were not working well.The capsular bag was not torn.The incision had to be enlarged and a lot of corneal edema occurred as a result.The doctor tried a back-up lens, which did not go in the eye as it was jammed in the injector.They decided then to implant a secondary lens type (model and diopter unknown).The patient was 20/400 one day post-op.No further information was provided.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6779201
• Report Number: 9614546-2017-00722
• Device Sequence Number: 10805688
• Product Code: HQL
• UDI-Device Identifier: 05050474602946
• UDI-Public: (01)05050474602946(17)200901
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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: 09/01/2020
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/09/2017
• 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