MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SIGNATURE PACK, DISPOSABLE TUBING; PHACO TUBING

Model Number	OPO71
Medical Device Problem Codes	Partial Blockage (1065); Kinked (1339)
Health Effect - Clinical Codes	Blurred Vision (2137); Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during cataract extraction in left eye the cartridge tubing (opo71 whitestar signature fusion fluidics) occluded due to a kink in the line.This resulted in loss of chamber (chamber collapse) and the posterior capsule was grabbed by the irrigation/aspiration hand piece tip.Tubing was changed to complete the case on the same day.It was reported that there was incision enlargement, sutures were done and vitrectomy was required.Patient reported being anxious and having blurry vision post op.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 10/04/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection with the unaided eye shows the kink was observed at the irrigation line near the white luer.The complaint was verified and confirmed for kink in line.A record review was performed.A product deficiency review was performed.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.No nonconformity report or documentation or labeling change is required.Product deficiency was confirmed.Corrective actions are to include additional assembly operation clarification details needed for making them easier to follow during execution by the operators.Operators were trained to the new revision of this manufacturing procedure.Operator awareness training regarding customer complaints for kinked or twisted tubing defects as well as re-training.Abbott medical optics will continue to monitor this type of complaints the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.All pertinent information available to the manufacturer has been submitted.

• Brand Name: SIGNATURE PACK, DISPOSABLE TUBING
• Common Device Name: PHACO TUBING
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6892920
• Report Number: 3006695864-2017-00797
• Device Sequence Number: 496615
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)190830(10)CB38746
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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
• Operator of Device: Physician
• Device Expiration Date: 08/30/2019
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention