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

Model Number ZCT400

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 11/20/2014

Event Type  Injury  

Event Description

It was reported that the intraocular lens (iol) was repositioned in a secondary procedure as the lens had rotated.The lens had rotated 35-40 degrees and induced 3.25 of cylinder.Lens was repositioned without complications and the patient was doing great.

Manufacturer Narrative

Explant date: if explanted, give date: not applicable (na) - to date, the intraocular lens remains implanted.(b)(4).Reason for non evaluation: to date, the intraocular lens remains implanted.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

Additional info: patient (relevant) history: hypertension, thyroid disease, diabetes (non-insulin dependent), non-smoker.Medications: hydrocodone-acetaminophen 10-325, metformin, pantoprazole, verapamil, ciprofloxacin, ilevro, optive, pred acetate.All pertinent information available to abbott medical optics has been submitted.

Event Description

Rotation detected 15 days post-op.Before iol was repositioned va (visual acuity) in the left eye (os) was 20/150 (uncorrected).Intraocular pressure (iop) within normal limits (wnl), low tear film.

Manufacturer Narrative

A review of the manufacturing records was performed.At final inspection all products are subject to cosmetic inspection prior to optical testing.The production order was released and there were no non conformances with respect to the final product release process.The production order was not produced under deviation.There were no process and/or material changes within the production order.The sterilization batch was released and there were no non conformances with respect to the sterilization process.The complaint related associated test is the optical measurement performed at final inspection.The in-line optical inspection data showed the lens was within specification in terms of optical and cylinder power.There were no environmental monitoring related non conformances.There were no associated nonconformity materials reports or non conformances or reports for deviations.A search on the production order was executed.The search revealed that no other complaints for this order were received to date.The lens met all manufacturing specifications prior to release.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: 4319229
• MDR Text Key: 17997972
• Report Number: 9614546-2014-00307
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• 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: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/13/2018
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2014; 01/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• 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