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

Model Number	ZCB00
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as this lens was inserted and removed.If explanted, give date: not applicable as this lens was inserted and removed.All pertinent information available to abbott medical optics has been submitted.Attempts have been made to obtain missing information; however, to date no response has been received.
Event or Problem Description
It was reported that a zcb00 26.5 diopter intraocular lens (iol) was inserted into the right eye (od) of the patient on (b)(6) 2018.The lens was replaced with the same model and diopter due to lens being rippled.There was no incision enlargement, vitrectomy, or sutures.Reportedly, there was no patient injury and the patient is doing fine post-operatively.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 02/22/2018.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that only half of the lens was returned.Loose fibers/particles and residue of lubricant material were observed on the lens piece, related to the handling of the unit out of a sterile environment.No damage was observed to the 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 johnson and johnson surgical vision, inc.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: 7229574
• Report Number: 2648035-2018-00169
• Device Sequence Number: 19124964
• Product Code: HQL
• UDI-Device Identifier: 05050474531840
• UDI-Public: (01)05050474531840(17)210524
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/09/2018

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: 05/24/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR