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

Model Number	ZCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was inserted and removed within the same procedure.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A scratch on a zcb00 intraocular lens (iol) was noticed after it was implanted.The iol was then removed in the same procedure.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Procedure was completed with a back-up lens.No injuries reported such as incision enlargement or vitrectomy.Date of birth: (b)(6) 1937.Age at time of event: (b)(6).Device available for evaluation ¿ yes, returned to manufacturer on 01/09/2017.Concomitant medical products: 1mtec30 cartridge, lot number: cb41388.Device returned to manufacturer ¿ yes.Device evaluation: the intraocular lens (iol) was observed to be cut.Only one part of the iol was received.Residues of what appears to be viscoelastic ovd (ophthalmic viscosurgical device) were detected in the iol.Some scratches were also observed at the optic zone, indicating the device was handled and prepared for surgical use.Visual inspection at 10x microscope magnification was performed.Small particles that could be related to handling the unit out of a controlled environment were observed on the surface of the iol.Some scratches were observed at the optic zone.The iol optic appears cut and ripped.Based on the evidence observed, the condition of the lens is consistent with a unit that has been damaged by the contact of the metal rod tip from the hand piece tool during the surgical process.The reported issue was 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 adequately provide instructions and precautions along with warnings for the proper use and handling of the device.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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6216742
• Report Number: 2648035-2016-02117
• Device Sequence Number: 425738
• Product Code: HQL
• UDI-Device Identifier: 05050474531598
• UDI-Public: (01)05050474531598(17)200317
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/17/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR