Home › Oculo-Plastik Inc › Khan-Jaeger SS Lid Plate for the Laser (non glare)

Khan-Jaeger SS Lid Plate for the Laser (non glare)

Oculo-Plastik Inc · Model 21-292 · UDI-DI 10697660002016

GAD

510(k) clearances

1,646

Adverse events (4 deaths)

Recalls

660

Facilities

Description

The Khan-Jaeger is a curved instrument partially non-glare for blepharoplasty. The usage of this instrument is to block laser beams, and retract the tissues during surgical intervention. It is used as a backstop or strip to press the tissue around the globe or press the globe itself. This technique makes the incision of the conjunctiva simpler and exposes the fat more easily. The polished part touches the ocular shield, which is inserted at the beginning of the procedure. The Khan-Jaeger has a more concave ergonomic design than the Jaeger, with the inside polished.

Recalls

Date	Firm	Reason
2026-06-05	Integra LifeSciences Corp. (NeuroSciences)	The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110
2025-04-09	MEDLINE INDUSTRIES, LP - Northfield	Three is the potential for the retractors to puncture through the sterile packaging.
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2024-05-17	SEASPINE ORTHOPEDICS CORPORATION	Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
2024-05-17	SEASPINE ORTHOPEDICS CORPORATION	Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2023-12-21	Medagent Inc	Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which
2023-05-25	TELEFLEX LLC	There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
2023-05-25	TELEFLEX LLC	There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
2022-12-08	Medtronic Navigation, Inc.	Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.