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

Model Number ZKB00

Device Problems Material Puncture/Hole (1504); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an intraocular lens (iol) was punctured by the inserter during insertion into the eye.Information for the inserter or cartridge was not provided.No further information was provided.

Manufacturer Narrative

Additional info: additional information was received and it was learned that the intraocular lens (iol) was fully inserted into the patient's eye and it was removed and replaced, during the same surgical procedure.No medical or surgical intervention was required.(b)(4).The inserter and cartridge model and lot number were also provided.Concomitant products: cartridge 1mtec30, lot cb36700; injector dk7796, lot 146.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 6155675
• MDR Text Key: 61858307
• Report Number: 9614546-2016-00663
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474560147
• UDI-Public: (01)05050474560147(17)200120
• 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,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/20/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• 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: INSERTER & CARTRIDGE: UNKNOWN MODELS, LOT/SN#