The Recall Desk
HighFDA (Devices)·Z-0711-2023·Announced 2022-12-21

DeRoyal surgical cataract pack subject to Class II recall

DeRoyal Industries voluntarily recalled 530 cataract surgical packs (Lot 57755800) classified as FDA Class II. The recall affects multiple U.S. states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall. Class II designates devices where serious adverse health consequences are possible. This qualifies as a risk-of-harm product. No illnesses, injuries, or deaths have been reported in available documentation.

Plain-English summary

DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal CATARACT PACK (Reference Number 89-8859.08). A total of 530 surgical kits with Lot Number 57755800 (expiration date 12/01/2026) have been recalled.

The specific reason for this Class II recall has not been disclosed in the available documentation. Class II recalls indicate that serious adverse health consequences are possible, though such consequences are considered less likely than in Class I recalls.

The affected cataract surgical packs were distributed across 23 U.S. states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi. The recall was initiated on November 3, 2022, and was reported to the FDA on December 21, 2022.

Healthcare facilities and medical professionals who have received cataract packs from this lot should immediately identify and quarantine affected materials. Facilities should contact DeRoyal Industries or consult the FDA recall notice for further instructions and information on product replacement or destruction.

The recalled product

Product
DeRoyal CATARACT PACK, REF 89-8859.08
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Ophthalmic Surgical Kit

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 57755800 exp 12/01/2026

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category