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

Model Number ZMA00

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 10/01/2014

Event Type  Injury  

Event Description

It was reported that after inserting the intraocular lens (iol) into patient's right eye, the physician realized that the lens haptic was bent, causing lens to not sit properly.Lens was removed and replaced with another lens.Additionally, it was noted that incision was enlarged but no vitrectomy was performed.No patient complications were reported.No further information has been provided.

Manufacturer Narrative

Additional concomitant product: emerald insertion system, serial number unknown.(b)(4).All pertinent information available to the manufacturer has been provided.Placeholder.

Manufacturer Narrative

The intraocular lens was returned to the manufacturer.One of the haptics is detached; the other haptic is still attached to the lens optic.Visual inspection at 12x magnification shows the lens can be identified as tecnis multifocal acrylic 3-piece intra ocular lens because of the type of haptics and the presence of a diffractive ring pattern on the optic.The lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.One of the haptics is missing; the other haptic is bent and has a crack at the location where the haptic is bent.The condition of the haptic that is present does not does not suggest or supports the crack and related bent haptic were introduced during manufacturing.All pertinent information available to the manufacturer has been submitted.

Manufacturer Narrative

Device evaluation: a review of the manufacturing records showed no deviations or nonconformities.The documentation showed that the production order was manufactured according to specifications.Dimensional inspection showed lens was within specifications.There are no associated nonconformity material reports with respect to the order number.Review of the sterilization records showed no deviations.Results of environmental monitoring records showed no deviations for the associated order number.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• 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: 4215598
• MDR Text Key: 21495909
• Report Number: 9614546-2014-00256
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080010
• 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,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/29/2018
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2013
• 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
• Treatment: EMERALDC30 CARTRIDGE, LOT CP00894
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR