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

Model Number ZKB00

Device Problem Material Distortion (2977)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was initially reported that the intraocular lens (iol) was being inserted into the patient's eye but there was an issue with the trailing haptic.Reportedly, the customer thought the lens was in the patient's eye but when the surgeon removed the inserter away from the eye, the lens was still with the cartridge.No patient injury was reported.In follow-up, it was reported that the lens was inserted into the patient's eye but stuck to the cartridge.As the surgeon was trying to release the lens and pull injector out, the whole lens came back out with it.The incision did not need to be any bigger or was a vitrectomy done.Reloaded the back-up lens and everything went smoothly.Patient is doing fine post-operatively with no complaints.

Manufacturer Narrative

The manufacturing record review was performed.There were no non conformances with respect to the final product release process.There is a deviation with respect to this production order; however, the deviation has no impact on product quality.Also, there is no relation between the deviation and the described complaint.The documentation shows that the production order was manufactured according to specifications.The product met manufacturing release criteria.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

The intraocular lens was returned to the manufacturer for evaluation.Visual inspection of the return sample showed that the lens was delivered in one piece.Visual inspection using a microscope at 12 x magnifications showed presence of dust particles and the lens is contaminated.No other anomalies were found; therefore, the reported complaint of the lens stuck to cartridge cannot be confirmed.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: stephanie solomon ; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 5016802
• MDR Text Key: 23528809
• Report Number: 9614546-2015-00205
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2015
• 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