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

Model Number	ZCT400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.(b)(4).Device evaluation: the product was not returned for evaluation.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that when inserting the intraocular lens (iol) into the eye, the doctor made a hole in the iol.The iol was removed during same surgery.The doctor had to cut the iol out and made sutures.Through follow up, the customer confirmed that the iol was fully inserted, there was no vitrectomy, and there was an incision enlargement.There was no serious patient injury.The number of sutures were unknown.The procedure was successfully completed using another iol.Additionally, the customer stated that the hole was not in the iol but in the capsular bag.There was no serious patient injury and no medical complications.No additional information was provided to abbott medical optics.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6675766
• Report Number: 9614546-2017-00578
• Device Sequence Number: 13470756
• Product Code: HQL
• UDI-Device Identifier: 05050474553996
• UDI-Public: (01)05050474553996(17)210330
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/30/2021
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/28/2017
• 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