MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS LAMINAR FLOW PHACO TIP 30D 21G INFSL; PHACO ACCESSORY

Model Number	OPOCR3021L
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).All pertinent information available to abbott medical optics at this time has been submitted.
Event or Problem Description
It was reported that during procedure, the laminar flow phaco tip was clogged.The operating room could not use five (5) of their phaco tips as they were clogged and did not allow irrigation.When the clogged tip issue was noted, the center changed the tip without consequence on the procedure.There was no patient involvement and no patient injury reported.This report is two (2) of five.
Additional Manufacturer Narrative
This is 2 of 5 supplemental reports:.Device available for evaluation ¿ yes, returned to manufacturer on 04/11/2018.Device returned to manufacturer ¿ yes.Device evaluation: five opocr3021l phaco tips were received within their original packaging confirming the reported lot number of 3821898.Four of the samples were still sealed inside both the inner and outer sterile pouches.The fifth sample was returned opened.A visual inspection of the opened phaco tip revealed an translucent silicone-like particle lodged in the tip.This report is for the tip that was not confirmed.The review of the device history record (dhr) for part no.Opocr3021l, lot # 3821898 showed that there were no issues or non-conformities.The batch record review was conducted with no defects and no additional information being found relating to this issue.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: LAMINAR FLOW PHACO TIP 30D 21G INFSL
• Common Device Name: PHACO ACCESSORY
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7278878
• Report Number: 3006695864-2018-00329
• Device Sequence Number: 11331207
• Product Code: HQC
• UDI-Device Identifier: 05050474537200
• UDI-Public: (01)05050474537200(17)200801(10)3821898
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/01/2020
• Device Model Number: OPOCR3021L
• Device Catalogue Number: OPOCR3021L
• Device Lot Number: 3821898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005