Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
Bausch & Lomb is recalling Stellaris Elite 25 GA Vit Cutters because the back cap may separate from the cutter body.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves a mechanical defect in a surgical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Bausch & Lomb Inc is recalling the Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV. This product contains the Stellaris Elite 25 GA Vit Cutter, Model BL5628, packaged in sterile trays. The recall involves 10 cases, specifically Lot number W0788 with an expiration date of 5/11/2019 and UDI 00757770059683.
The recall was initiated because the back cap separates from the body of the vitrectomy cutter. This defect could potentially compromise the integrity of the device during use.
Distribution was made to 26 U.S. states and 17 foreign countries, including Russia, Romania, Poland, and Great Britain. The source text does not specify the number of affected units beyond the 10 cases or report any specific injuries or illnesses. Users should check their inventory for this specific lot number and contact Bausch & Lomb for instructions on returning the product.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
- Manufacturer
- Bausch & Lomb Inc
- Affected units
- 10
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 (3)
- Lot number W0788
- exp. 5/11/2019
- UDI 00757770059683.
Distribution
Part of a larger recall action
This product is one of 13 recalled by Bausch & Lomb Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Bausch & Lomb Inc
See all →- HighBausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateBausch + Lomb Stellaris PC Vision Enhancement System Recall
FDA (Devices) · 2012-12-26
- HighBausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly
FDA (Devices) · 2014-12-31
- HighBausch & Lomb SofPort Advanced Optics Aspheric Lens Recall for Haptic Breakage
FDA (Devices) · 2015-07-29
- HighSurgical Cataract Pack Recalled Due to Compromised Sterile Packaging
FDA (Devices) · 2022-11-09
- HighSurgical Cataract Kits Recalled for Defective Breather Pouch Seals
FDA (Devices) · 2022-11-09
- HighBausch & Lomb Recalls SoftPort Easy-Load Lens Delivery System
FDA (Devices) · 2017-05-24