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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.If implanted, give date: not applicable, as the lens was not fully implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during insertion of a zcb00 16.5 diopter intraocular lens (iol), a hole was observed in capsule.Due to the hole, the physician removed the lens and replaced it with a model za9003 iol.There was no incision enlargement, no vitrectomy and no post-op patient injury reported.Customer could not confirm if the hole was due to patient issue or if was due to the lens implant.No further information was provided.
Additional Manufacturer Narrative
Corrected data: initially, it was reported that no incision enlargement was performed; however, this was incorrect.Through follow up it was confirmed that incision enlargement was required.Furthermore, the complaint reporter was indicated as not a healthcare professional.This information is also incorrect.According to the new information received, the complaint reporter is a nurse.Health professional - yes.Occupation - nurse.(b)(4).Additional information: according to the additional information received, this event involves a (b)(6) female patient.Additionally, was also noted that dr.Robertson was the physician.(b)(6).Gender/sex: female.Device available for evaluation ¿ yes, returned to manufacturer on 02/13/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed and residues of what appears to be viscoelastic ovd (ophthalmic viscosurgical device) were detected in the iol, indicating the device was handled and prepared for surgical use.The lens was observed cut in two half of optic zone.Both haptics were observed to be in good shape.Based on the evidence observed, the condition of the lens is consistent with a unit that handled during surgical process for removal and replacement.The reported issue could not be verified in the sample return.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional investigations requests for this po number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6301432
• Report Number: 2648035-2017-00214
• Device Sequence Number: 16546720
• Product Code: HQL
• UDI-Device Identifier: 05050474531642
• UDI-Public: (01)05050474531642(17)200813
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2017

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: 08/13/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 03/12/2017
• 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: 65 YR