Constellation Vision System

• 2 recalls, same reason

  • Ongoing Z-0305-2026 FDA Class II ·initiated 5 Aug 2025 ·on shared 510(k) K141065
  • Ongoing Z-0304-2026 FDA Class II ·initiated 5 Aug 2025 ·on shared 510(k) K141065

  Due to incomplete seals in the pouch which provide the sterile barrier.

• 2 recalls, same reason

  • Ongoing Z-2109-2025 FDA Class II ·initiated 28 Apr 2025 ·on shared 510(k) K141065
  • Ongoing Z-2108-2025 FDA Class II ·initiated 28 Apr 2025 ·on shared 510(k) K141065

  Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

• • Ongoing Z-0099-2024 FDA Class II ·initiated 18 Aug 2023 ·on shared 510(k) K141065

  Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

• • Ongoing Z-2406-2023 FDA Class II ·initiated 28 Jun 2023 ·on shared 510(k) K141065

  Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K141065 ↗

FDA Product Code

HQE

Device Class

Class II

Regulation

21 CFR Part 886.4150

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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