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

Model Number ZMB00

Device Problem Material Distortion (2977)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when inserting into the patient's eye, the patient moved causing contact with the intraocular lens and the lens crinkled.No further information was provided.

Manufacturer Narrative

Device evaluation: the intraocular lens was returned to the manufacturer for evaluation.The lens was inspected with magnification.The lens was contaminated, dust particles were present indicating its exposure to the non-sterile, non-environmental controlled area.On the posterior side of the lens a deep scratch observed.The type of damage does not suggest the scratch was introduced during manufacturing.Reportedly, during surgery the patient moved causing contact with the lens and the lens crinkled.The manufacturing record and related documents show that the production order was manufactured according to specifications.During manufacturing process, all products are subject to cosmetic inspection.During the manufacturing record review of the production order for this serial number, no related non- conformances or deviations were identified.A search on complaints related to production order was conducted and revealed that no other complaints for this order number have been received.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and warnings related to halos and glare.Based on the investigation results, reported complaint was confirmed.The type of damage does not suggest the scratch was introduced during manufacturing.Most probably the event is related to use or the surgical procedure.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: 5318409
• MDR Text Key: 34133333
• Report Number: 9614546-2015-00370
• Device Sequence Number: 1
• Product Code: MFK
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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