Light Adjustable Lens (LAL) 60007-0100Recalls & reported problems
Rxsight, Inc. · LAL, Sterile, Packaged, 5.0 Diopter · Class 3 · Implant
All models of Light Adjustable Lens (LAL) (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806021439), received between Mar 25, 2025 and Jun 26, 2025 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +10.0D) WAS EXPLANTED DUE TO BLURRY VISION.
Patient problems: Blurred Vision
MAUDE report 22342665 ↗InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +10.0D) WAS EXPLANTED DUE TO DISSATISFACTION WITH NEAR VISION.
Patient problems: Visual Impairment
MAUDE report 21689465 ↗
Other Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) devices
- RxSight Light Adjustable Lens (RxLAL) 60005-3205Rxsight, Inc. · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)50 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3200Rxsight, Inc. · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)47 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3210Rxsight, Inc. · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)39 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3190Rxsight, Inc. · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)32 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3195Rxsight, Inc. · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)31 reports
- Light Adjustable Lens (LAL) 60007-0200Rxsight, Inc. · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)31 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3215Rxsight, Inc. · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)30 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3185Rxsight, Inc. · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)29 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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