FDA Adverse Event Malfunction Summary report: N

SIGNATURE PACK, DISPOSABLE TUBING

MDR report key: 2010334 · Received February 11, 2011

Report

Report Number: 2648035-2011-00001
Event Type: Malfunction
Date Received: February 11, 2011
Date of Event: January 14, 2011
Report Date: January 14, 2011
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HQC
PMA / PMN Number: K060366
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE UNSEALED TRAY WAS RETURNED TO ABBOTT MEDICAL OPTICS BEFORE FORWARDING TO MFR SITE FOR EVALUATION. UPON VISUAL INSPECTION, BOTH SIDES OF THE TRAY REVEALED THE SEAL WAS PARTIALLY LIFTED. THERE WAS A SLIGHT DAMPNESS TO THE TRAY LID. A DEVICE HISTORY RECORD REVIEW REVEALED THE TUBING PACK LOT NUMBER CH01257 DOES NOT HAVE ANY COMMENT, OBSERVATION OR DEVIATION RELATED TO THE COMPLAINT REPORTED. BASED ON OUR RECORDS, THIS IS THE FIRST COMPLAINT REC'D REPORTING STERILITY ISSUES AT THE MFG SITE FOR THE LOT. THE STERILIZATION PROCESS DOCUMENTS WERE VERIFIED AND THE CYCLE HAD NO DEVIATIONS THAT COULD AFFECT THE STERILITY ASSURANCE LEVEL OF PRODUCT. THE PRODUCT WAS PROCESSED ACCORDING TO AMO REQUIREMENTS AND THE CYCLE SHOWED NO PROCESS ALARMS. AS A RESULT, ALL PRODUCTS WERE RELEASED WITHIN SPECIFICATION. THE INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADD'L REPORTABLE INFO BECOMES ACCESSIBLE.

Description of Event or Problem · 1

A DISTRIBUTOR REPORTED THAT DURING PRODUCT INSPECTION ONE PHACO TUBING PACK WAS OBSERVED TO HAVE TWO OF FOUR CORNERS WERE PARTIALLY UNSEALED AT THE TRAY LID. AN UNSEALED TRAY CAN COMPROMISE STERILITY THEREFORE THE PRODUCT WAS RETURNED TO THE MFR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SIGNATURE PACK, DISPOSABLE TUBING		HQC	ABBOTT MEDICAL OPTICS	OPO71	CH01257

Patients

Seq	Age	Sex	Outcome	Treatment
1