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

Model Number ZMB00

Device Problems Detachment Of Device Component (1104); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a zmb00 intraocular lens (iol) was implanted on (b)(6) 2016.After implantation, haptic separation was detected.Reportedly, the lens could not be centered without the second haptic.Visual acuity pre-op was 20/30 in the right eye (od) and 20/30 in the left eye (os).Post-op (implant) od was 20/70 and os was 20/30.On (b)(6) 2016, the lens was removed and replaced in a second surgery using the original incision.The explant was done after six (6) days because there was no other zmb00 lens available at the time of initial implant.No other patient injury reported.Reportedly, visual acuity after the second surgery was 20/30 j1 in the right eye and 20/20 j1 in the left eye.The explanted lens was discarded.No further information was provided.

Manufacturer Narrative

Device evaluation: visual inspection was not performed as complaint device was not returned for analysis.Therefore the complaint cannot be confirmed.  the manufacturing production order (po) was evaluated and the devices were manufactured within specifications.The units were released according to specification.There is no associated deviation or non-conformity report related to this complaint.The complaint related test is the dimensional inspection performed at lens generation.The results of the dimensional testing show all dimensions are within specification.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.

• 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: 5572008
• MDR Text Key: 42489478
• Report Number: 9614546-2016-00174
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/25/2019
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00I0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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
• Patient Age: 65 YR