MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number ZCB00

Device Problem Kinked (1339)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

All pertinent information available to abbott medical optics has been submitted.

Event Description

After intraocular lens (iol) implantation, it was noted that the iol was kinked/crimped.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Additional information: through follow up with the location contact additional information was provided.The location contact noted there is no indication of an incision enlargement or vitrectomy.The haptic was stuck in the cartridge.After implantation, the lens was kinked and the capsule broke.The lens was removed and replaced with a non-amo lens.The customer cannot say if the capsule broke due to the lens and if the haptic detached from the optic.Based on the additional information that has been provided the following updates have been made to the information provided on the initial mdr: on the initial mdr only product problem was indicated however with the additional information provided both adverse event and product problem have now been indicated.Outcomes attributed to adverse event: other: capsule tear.Device available for evaluation? yes, returned to manufacturer on 1/25/2017.Device returned to manufacturer? yes.Device evaluation: the complaint unit was received in the original folding carton.Visual inspection at 10x microscope magnification was performed.The lens edge was observed to be smooth including the haptics.The haptics were undamaged.The lens was undamaged.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6232194
• MDR Text Key: 64126409
• Report Number: 2648035-2017-00037
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531772
• UDI-Public: (01)05050474531772(17)200914
• 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: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/14/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• 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
• Patient Outcome(s): Other