REFERENCE UNIT
Received Mar 13, 2015 · Event occurred Dec 16, 2014
Report 3010300699-2015-00001 · MDR key 4605195
Device
Generic name
Keratometer, Pupillometer
Manufacturer
Wavelight Gmbh AgpsModel number
X-RUSCatalog number
8065998240
Lot number
NA
Product problems
- Improper Device Output
Patient
63 YR
- Blurred Vision
- Postoperative refraction, unexpected
Narrative
Description of Event or Problem
A SURGEON REPORTED THAT HE IMPLANTED A TORIC INTRAOCULAR LENS (IOL), AS SUGGESTED BY THE CALCULATIONS OF THE SYS'S SOFTWARE. THE PT PRESENTED WITH ADD'L ASTIGMATISM AND BLURRED VISION, POSTOPERATIVELY. THE SURGEON EXCHANGED THE TORIC IOL FOR A SINGLE VISION IOL OF THE SAME POWER, AND THE EVENT RESOLVED. NO FURTHER INFO IS EXPECTED.
Additional Manufacturer Narrative
EVAL SUMMARY: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).