BOSTON SIMPLUS MULTI-ACTION SOLUTION

Report

Report Number: 1313525-2008-00019
Event Type: Injury
Date Received: June 10, 2008
Date of Event: April 1, 2008
Report Date: May 12, 2008
Manufacturer: BAUSCH & LOMB
Product Code: LPN
PMA / PMN Number: K024289
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

NO DEVICE WAS RETURNED FOR EVAL. A REVIEW OF THE LOT BATCH RECORDS AND TESTING OF RETAIN SAMPLES SHOW THAT ALL REQUIREMENTS WERE MET. PT REPORTED SHE HAS KERATOCONUS AND AT SOME POINT WAS EXPECTED TO HAVE A CORNEAL TRANSPLANT. PT WOULD NOT PROVIDE DR INFO OR SIGN A MEDICAL RELEASE AND THEREFORE, THE EVENT WAS NOT CONFIRMED BY A HEALTH CARE PROVIDER AND NO FURTHER INFO COULD BE OBTAINED. BASED ON ALL AVAILABLE INFO, NO ROOT CAUSE CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

Description of Event or Problem · 1

PER AN EMAIL REC'D FROM THE PT, SHE HAS KERATOCONUS AND AT SOME POINT WAS EXPECTED TO HAVE A CORNEAL TRANSPLANT. PT PURCHASED A NEW BOTTLE OF SOLUTION AND EXPERIENCED BURNING UPON INSERTION OF THE CONTACT LENSES AND TOOK THE CONTACTS OUT. PT USED A DIFFERENT PROD, BUT CONTINUED TO HAVE PROBLEMS WITH GETTING AND KEEPING HER CONTACTS IN. THE LEFT EYE IMPROVED, BUT THE RIGHT EYE CONTINUED TO BE SORE. SHE CONTACTED HER DR TO DISCUSS THE CAUSE OF BURNING. THE DR SUGGESTED THAT NOW WOULD BE A GOOD TIME FOR THE CORNEAL TRANSPLANT AND ADVISED TO DISCONTINUE CONTACT LENS WEAR IN HER RIGHT EYE. PER THE PT, SHE IS SCHEDULED FOR A CORNEAL TRANSPLANT OF HER RIGHT EYE IN 2008 AND ATTRIBUTES THE SURGERY TO THE PROD. THE PT REFUSED TO SIGN THE MEDICAL RELEASE AND HAS NOT RESPONDED TO REPEATED ATTEMPTS TO OBTAIN ADD'L INFO.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BOSTON SIMPLUS MULTI-ACTION SOLUTION	86LPN	LPN	BAUSCH & LOMB		GK7060

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention