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

Model Number	OPO71
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth is unknown as it was not provided.Patient gender is unknown as it was not provided.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
During a cataract extraction procedure, the surgery center reported a posterior capsule rupture requiring a vitrectomy procedure.A brief description from the surgery center indicated the capsular rupture occurred before the position two was activated on the footpedal when using the disposable tubing pack.The surgery center reported the procedure was delayed for about 30 minutes.
Additional Manufacturer Narrative
Visual inspection was performed.Visual inspection revealed that sample was not returned in its original package.Sample returned with priming solution, drain bag and spike drip cut off which indicates that product was handled and prepare for surgical use.No assembly error and/or defect related to manufacturing process were observed in the unit.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.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.The review of the device history record (dhr) for signature pack, disposable tubingshowed that there were no issues or non-conformities.Manufacturing has been ruled out as a potential cause for the reported issue.No conclusive evidence identified for reported issue.The system was working within amo specifications.The reported complaint was not verified and no product deficiency was identified.All pertinent information available to abbott medical optics 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: 6165570
• Report Number: 2648035-2016-01983
• Device Sequence Number: 19001701
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)190224(10)CB26844
• Combination Product (Y/N): N
• 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): 01/04/2017

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: 02/24/2019
• Device Model Number: OPO71
• Device Lot Number: CB26844
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 01/05/2017
• 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