MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number 14577

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

A product sample has been received by the manufacturer and it is awaiting evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A nurse reported that lint was observed and removed from a patient's eye following a cataract procedure.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the surgeon who indicated that a blue filament was found in the keratotomy of the left eye, one day after the phacoemulsification procedure.

Manufacturer Narrative

The lot specific to this event was not known; therefore, a lot history and device history record (dhr) reviews were not performed.A visual inspection found one piece of sponge like material returned with black foreign material enclosed in a specimen cup.The customer circled the black foreign material with a marker.A microscopic examination at the particulate lab showed a small, black particles.The black particles were isolated and analyzed.The best match was mascara.Though the definitive origin of the returned black foreign material found on the sponge like material cannot be determined, the most likely root cause is related to the pack manufacturing process.Two other potential root causes include an error made during the supplier's manufacturing process and possibly other components in the pack.

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5873795
• MDR Text Key: 52059196
• Report Number: 1644019-2016-01115
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14577
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention
• Patient Age: 83 YR