Abbott AMO Vitrectomy Cutters Recalled for Packaging Error
Abbott Medical Optics is recalling 360 AMO Vitrectomy Cutters because 20GA and 25GA models may be packaged in the wrong sizes.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because the source text identifies the issue as a 'Packaging error' with no reported injuries, illnesses, or deaths, fitting the rubric criteria for packaging-only problems.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 360 units of AMO 25GA Vitrectomy Cutters (Model Number NGP0025) and AMO 20GA Vitrectomy Cutters and Irrigation Sleeves (Model Number NGP0020). These devices are used with the AMO Whitestar Signature System for ophthalmic use.
The recall is due to a packaging error where 20GA Vitrectomy Cutters may be found in a 25GA package, and 25GA Vitrectomy Cutters may be found in a 20GA package. The affected units include 72 units of Part Number NGP0025 (Lot CA06182) and 288 units of Part Number NGP0020 (Lot CA06180).
The products were distributed worldwide to South Africa, Turkey, Arizona, Netherlands, Portugal, Singapore, Australia, Japan, and Hong Kong. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these specific units.
The recalled product
- Product
- AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 360
Distribution
Distribution scope not specified by the agency.
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