Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2018-09-26 | NAI | No action indicated | Peregrine Surgical Ltd | 0 |
| 2018-09-26 | NAI | No action indicated | Peregrine Surgical Ltd | 0 |
| 2015-06-19 | VAI | Voluntary action indicated | Peregrine Surgical Ltd | 0 |
| 2015-06-19 | VAI | Voluntary action indicated | Peregrine Surgical Ltd | 0 |
| 2013-02-07 | VAI | Voluntary action indicated | Peregrine Surgical Ltd | 1 |
| 2013-02-07 | VAI | Voluntary action indicated | Peregrine Surgical Ltd | 1 |
| 2011-06-30 | VAI | Voluntary action indicated | Peregrine Surgical Ltd | 0 |
| 2011-06-30 | VAI | Voluntary action indicated | Peregrine Surgical Ltd | 0 |
| 2010-12-20 | WL | Warning Letter | Peregrine Surgical Ltd | — |
| 2010-12-20 | WL | Warning Letter | Peregrine Surgical Ltd | — |
| 2010-07-15 | OAI | Official action indicated | Peregrine Surgical Ltd | 6 |
| 2010-07-15 | OAI | Official action indicated | Peregrine Surgical Ltd | 6 |
Similar devices
- 20GA Curved Laser Probe with Alcon adaptor D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 20GA Straight Laser Probe with Alcon adaptor D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 20ga Curved Illuminated Laser Probe, 19ga Needle Illumination, Alcon KATALYST SURGICAL LLC
- 20ga Curved Illuminated Laser Probe, 19ga Needle Illumination, DORC KATALYST SURGICAL LLC
- 20ga Curved Illuminated Laser Probe, 19ga Needle Illumination, Iridex KATALYST SURGICAL LLC
- 20ga Curved Illuminated Laser Probe, 19ga Needle Illumination, Nidek KATALYST SURGICAL LLC
- 20ga Curved Illuminated Laser Probe, 19ga Needle Illumination, Quantel KATALYST SURGICAL LLC
- 20ga Curved Laser Probe, Alcon KATALYST SURGICAL LLC
- 20ga Curved Laser Probe, DORC KATALYST SURGICAL LLC
- 20ga Curved Laser Probe, Iridex KATALYST SURGICAL LLC
- 20ga Curved Laser Probe, Nidek Thread KATALYST SURGICAL LLC
- 20ga Curved Laser Probe, Quantel KATALYST SURGICAL LLC
Select up to two to place side-by-side with this device.