MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number ZMB00

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 10/09/2014

Event Type  Injury  

Event Description

It was reported that the intraocular lens (iol) was inserted into the eye.The doctor noticed that the end of haptic was sheared off.The doctor had to cut lens out of eye and take it out in several small pieces.The lens was replaced with the same type of lens and there was no harm to the patient.The incision was made larger; sutures were not needed.No further information was provided.

Manufacturer Narrative

(b)(4).All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

Additional information: gender - female.Additional information: left eye.Manufacturing record review: the manufacturing record review was performed.There were no nonconformances with respect to the final product release process.The results show all dimensions are within specification.There are no associated nonconformity material reports with respect to when the production order number was manufactured.There are no complaint related environmental monitoring related nonconformances within the timeframe that the production order was manufactured.There were no process and / or material changes within the production order number.There were no nonconformances with respect to the sterilization process.Based on the manufacturing record review and historical review the product met manufacturing release criteria.All pertinent information available to abbott medical optics at the time of this report has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Type of Device: MULTIFOCAL 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: 4218355
• MDR Text Key: 5040640
• Report Number: 9614546-2014-00259
• Device Sequence Number: 1
• Product Code: MFK
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/24/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• 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