MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number ZXT150

Device Problems Fracture (1260); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a zxt150 18.0 diopter intraocular lens (iol) was scratched during implantation and an unspecified surgical intervention was required.No additional information was provided.

Manufacturer Narrative

Additional information was received and it was learnt that there were no indications of resistance during the intraocular lens (iol) implantation.The lens was fully inserted into the patient's eye and it was being manipulated when the scratch/crack was noted.There was an actual fracture in the center of the iol.Reportedly, the lens was removed and replaced during the same surgical procedure with no further issues.No incision enlargement, no vitrectomy was performed, no sutures were used and no injury was reported.The patient did not have any post-op complications.Date of birth: (b)(6).The surgeon's name was provided: dr (b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was cut in pieces, most probably to make the removal possible.Considering the condition of the lens additional analysis was not possible.The customer's reported complaint could not be 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 similar complaints 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 could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Type of Device: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6933652
• MDR Text Key: 89957047
• Report Number: 9614546-2017-00967
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474605169
• UDI-Public: (01)05050474605169(17)211213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/13/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR