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

Model Number ZLB00

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 06/23/2016

Event Type  Injury  

Manufacturer Narrative

Udi #: (b)(4).Age/date of birth: unknown/not provided.(b)(4).Device evaluation: complaint device was not returned for analysis.The complaint cannot be confirmed.The manufacturing production order (po) was evaluated and the devices were manufactured within specifications.The unit`s were released according to specification.There is no associated deviation or non-conformity report related to this complaint.The complaint related test is the optical measurement performed at final inspection.The in-line optical inspection data was reviewed and results showed that the lens was manufactured within power specification.A review of the complaints related to the production order was performed and the results revealed that no other complaints for this order number.A historical complaint data review was performed and results did not identify any product deficiency.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the manufacturing record review, complaint data review and labeling review, no product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a zlb00 intraocular lens (iol) was explanted from the patient's right eye as wrong iol power was selected.No further information was provided.

• 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: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5814514
• MDR Text Key: 50175960
• Report Number: 9614546-2016-00353
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/03/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2015
• 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