FDA Adverse Event Injury Summary report: N

ORA SYSTEM 2000

MDR report key: 17371986 · Received July 21, 2023

Report

Report Number: 2028159-2023-01031
Event Type: Injury
Date Received: July 21, 2023
Date of Event: April 17, 2023
Report Date: October 16, 2023
Manufacturer: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
Product Code: NCF
PMA / PMN Number: EXEMPT
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H.3., H.6.: 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative · 0

ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem · 0

A CUSTOMER REPORTED THAT AN EXPLANTED INTRAOCULAR LENS WITH A DIFFERENT POWER OF LENS AND POOR VISION WITH BEST CORRECTED VISUAL ACUITY LOSS OF TWO LINES, REFRACTIVE AXIS VALUE THAT WAS THIRTY DEGREES OFF WITH REFRACTIVE SURPRISE LESS THAN TWO DIOPTER IN THE RIGHT EYE OF A PATIENT, AFTER SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1873512	ORA SYSTEM 2000	ABERROMETER, OPHTHALMIC	NCF	ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR	Male	Other	CLAREON VIVITY TORIC\| CLAREON VIVITY TORIC IOL\| MONARCH III IOL CARTRIDGE D\| MONARCH III IOL INJECTOR\| PROVISC OPHTHALMIC