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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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 an intraocular lens (iol) was implanted.When the patient came out of the operating room, the surgeon changed his mind on what iol he wanted implanted and took the patient back to the operating room to exchange the lens.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
During follow up, the customer stated that the doctor who performed the procedure realized that he had implanted the wrong intraocular lens (iol) and quickly removed the iol from the patient.The customer stated that there was no labeling issue with the product.No vitrectomy or incision enlargement performed except for sutures used to implant the new iol.The patient was fine post-surgery.The product was discarded.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product was not returned for investigation.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.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.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6565215
• Report Number: 9614546-2017-00413
• Device Sequence Number: 13679149
• Product Code: HQL
• UDI-Device Identifier: 05050474552678
• UDI-Public: (01)05050474552678(17)210206
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2017

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: 02/06/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 08/16/2017; 09/10/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 09/11/2017; 10/03/2017
• 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