MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: only year of birth provided (b)(6).Implant t and explant dates: if implanted or explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported to that the doctor implanted a lens in the wrong patient.There were no issues with the quality of the product.The lens was inserted in the right eye and removed during the same procedure.The incision was enlarged.A vitrectomy was not performed.Reportedly the lens was replaced with another pcb00.No patient symptoms.The patient¿s outcome is normal.No other medical/surgical intervention required.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since no product was 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 additional 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.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6953902
• Report Number: 2648035-2017-01891
• Device Sequence Number: 13730958
• Product Code: HQL
• UDI-Device Identifier: 05050474558403
• UDI-Public: (01)05050474558403(17)200508
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 05/08/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 11/18/2017
• 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
• Patient Age: 76 YR