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VISIAN ICL (IMPLANTABLE COLLAMER LENS) Adverse Event — Malfunction (MDR 2023826-2008-00237)

VISIAN ICL (IMPLANTABLE COLLAMER LENS) Adverse Event — Malfunction (MDR 2023826-2008-00237) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VISIAN ICL (IMPLANTABLE COLLAMER LENS); Generic name: INTRAOCULAR LENS; Manufacturer: STAAR SURGICAL CO..

DeviceVISIAN ICL (IMPLANTABLE COLLAMER LENS)
Generic nameINTRAOCULAR LENS
ManufacturerSTAAR SURGICAL CO.
Report number2023826-2008-00237
Event typeMalfunction
Product problemY
Date received2008-02-21
Report sourceHealth Professional
NarrativeTHE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS BUT THE LENS BECAME STUCK IN THE CARTRIDGE AND THE SURGEON WAS UNABLE TO PUSH THE LENS THROUGH. WHEN THE SURGEON WAS ABLE TO PUSH THE LENS OUT, THE HAPTICS WERE TORN OFF. THERE WAS NO PT CONTACT.
SourceopenFDA MAUDE (device adverse events)

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