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

Model Number ZCT150

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 10/31/2014

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.The lens was received cut in pieces, most probably to make the explant possible.Visual inspection using a microscope at (b)(4) magnification showed that the lens can be identified as a tecnis toric acrylic 1-piece intra ocular lens because of the type of haptics and the presence marking holes.The lens was received with dust particles present.The lens condition is consistent with a lens that was removed from the patient's eye.Due to the received condition of the lens additional analysis could not be performed.All pertinent information available to the manufacturer has been submitted.

Event Description

On (b)(6) 2014, it was reported to the amo sales representative that the intraocular lens (iol) will be explanted.On (b)(6) 2014, lens was explanted from patient's left eye, due to mechanical complications with the lens.Incision was enlarged but vitrectomy was not performed.A replacement lens was placed.Replacement lens is of the same model but different diopter (zct150 diopter 18.5), serial number (b)(4).No patient complications were reported.Patient was noted to be doing very good and very happy with vision, post-operatively.No further information has been provided.

Manufacturer Narrative

(b)(4).All pertinent information available to the manufacturer has been submitted.Placeholder.

Manufacturer Narrative

The manufacturing records were reviewed.Device history records were reviewed.The device was produced without deviations or non-conformances.There were not process and/or material changes.No other complaints have been received for the production order.The product met manufacturing release specifications.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: stephanie solomon ; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 4267675
• MDR Text Key: 19013152
• Report Number: 9614546-2014-00287
• Device Sequence Number: 1
• Product Code: MJP
• 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 Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2014

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/09/2017
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2014; 01/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• 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: 63 YR