FDA Adverse Event Injury Summary report: N

ORA SYSTEM 2000

MDR report key: 7096808 · Received December 7, 2017

Report

Report Number: 2028159-2017-04497
Event Type: Injury
Date Received: December 7, 2017
Date of Event: November 7, 2017
Report Date: April 16, 2018
Manufacturer: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Product Code: NCF
PMA / PMN Number: EXEMPT
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INTRAOCULAR LENS (IOL) POWER RECOMMENDED BY THE SYSTEM MAY HAVE INFLUENCED THE READING WHICH LED TO A MILDLY HYPEROPIC REFRACTIVE OUTCOME. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

Additional Manufacturer Narrative · 1

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).

Description of Event or Problem · 1

AN ORTHOPTIST REPORTED AN UNUSUAL PREDICTED OUTCOME DURING A CATARACT SURGERY ON A PATIENT'S RIGHT EYE. REFRACTIVE ANALYZER PREDICTION IF FULLY ACCEPTED WOULD HAVE LED TO THE PATIENT BEING SIGNIFICANTLY LONG SIGHTED. AS IT IS, THE INTRAOCULAR LENS (IOL) POWER RECOMMENDATION INFLUENCED THE READING AND LED TO A MILDLY HYPEROPIC REFRACTIVE OUTCOME. THERE WAS NO REPORTED PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. THE ANALYZER RECOMMENDATION WAS NOT COMPLETELY ADHERED TO, AS THERE WAS SIGNIFICANT DISCREPANCY FROM OTHER CALCULATION METHODS. THE SURGERY WAS COMPLETED ON THE SAME DAY. PATIENT IS HAPPY WITH VISUAL OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
874858	ORA SYSTEM 2000	ABERROMETER, OPHTHALMIC	NCF	ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other