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

Model Number ZCT150

Device Problems Bent (1059); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 04/08/2015

Event Type  Injury  

Event Description

The account reported distorted/bent haptic with an intraocular lens (iol).It was reported that the issue was during handling/use error.It was reported that there was an incision enlargement and a suture was used.Another lens was used with the same model and diopter.No further information was provided.

Manufacturer Narrative

(b)(4).The manufacturing record review was performed.There were no non-conformances with respect to the final product release process.The production order was not produced under deviation.All tests results showed a pass condition.During the manufacturing record review of the production order for this serial number, no deviation or assignable cause was identified for the complaint type reported or related to the initial report information when this production order was manufactured.The documentation showed that the production order was manufactured according to specifications.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

(b)(4).The intraocular lens (iol) was returned to the manufacturing site for investigation.Visual inspection using a microscope at 12x magnification showed the lens identified as tecnis toric acrylic 1-piece intraocular lens because of the type of haptics and the presence of marking holes.The lens was delivered in one piece.No anomalies were found in the returned lens sample.Visual inspection of the returned lens sample did not show any non-conformances.The reported complaint could not be confirmed based on the analysis.All pertinent information available to abbott medical optics 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: 4872766
• MDR Text Key: 5860802
• Report Number: 9614546-2015-00151
• Device Sequence Number: 1
• Product Code: HQL
• 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,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/26/2018
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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
• Patient Age: 74 YR