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

Model Number	ZCB00
Medical Device Problem Codes	Crack (1135); Environmental Compatibility Problem (2929)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, not provided.If implanted, give date: not applicable no patient involvement reported.If explanted, give date: not applicable no patient involvement reported.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was cracked.No patient involvement or injury was reported.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the lens was cracked as the surgeon started implanting the lens.The surgeon commented that it was the first morning case and the theatre was really cold so that could have caused the lens to crack.No further information was provided.(b)(4).Device available for evaluation? yes.Returned to manufacturer on: 06/09/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed fibers/particles and residue of viscoelastic solution on the lens, indicating that the unit was handled and prepare for surgical use.The lens was observed with a large cut and with one of the haptics detached.The detached haptic piece was not returned.No damages were observed to the other haptic.The customer's reported complaint was verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional investigation requests for this order number have been received.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was verified.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: 6628987
• Report Number: 2648035-2017-01029
• Device Sequence Number: 1049262
• Product Code: HQL
• UDI-Device Identifier: 05050474531598
• UDI-Public: (01)05050474531598(17)200806
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2017

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: 08/06/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1