RxSight Light Adjustable Lens (RxLAL)Recalls & reported problems across all models
Rxsight, Inc. · 62 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 734
- Deaths reported
- 0
- Injuries reported
- 718
- Recalls
- 0
We found 62 models of RxSight Light Adjustable Lens (RxLAL) by Rxsight, Inc. in the FDA's device registry (GUDID). Together they are named in 734 adverse event reports in the FDA's MAUDE database, received between May 1, 2019 and Sep 28, 2026 — classified as 718 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (114 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RxSight Light Adjustable Lens (RxLAL) problems
Device problems
- Adverse Event Without Identified Device or Use Problem371
- Optical Problem114
- Use of Device Problem51
- Optical Distortion43
- Patient-Device Incompatibility41
- Insufficient Device Problem Information38
- Optical Decentration36
- Improper or Incorrect Procedure or Method21
Patient problems
- Visual Impairment226
- Blurred Vision157
- Visual Disturbances142
- Unspecified Eye / Vision Problem102
- Capsular Bag Tear96
- No Clinical Signs, Symptoms or Conditions30
- Diplopia/Double Vision16
- Insufficient Information10
RxSight Light Adjustable Lens (RxLAL) models
62 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RxSight Light Adjustable Lens (RxLAL) 60005-3205Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)50 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3200Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)47 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3210Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)39 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3190Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)32 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3195Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)31 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3215Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)30 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3185Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)29 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3220Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)29 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3225Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)28 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3180Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)27 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3230Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)21 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3240Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)20 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3140Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)19 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3175Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)19 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3235Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)18 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3160Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)18 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3170Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)17 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3250Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)16 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2190Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)15 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2195Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)14 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3130Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)14 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2180Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)13 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2200Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)13 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2215Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)13 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2220Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)12 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3150Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)12 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3165Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)11 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2225Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)10 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3260Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)10 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2205Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)9 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2230Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)9 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2185Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)6 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2210Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)6 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2165Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)5 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2240Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)5 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3120Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)5 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3080Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)5 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2250Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)4 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2270Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)4 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3090Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)4 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2150Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)3 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2170Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)3 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3110Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)3 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3300Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)3 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3040Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)3 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3060Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)3 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3070Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)3 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2100Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2130Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2140Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2160Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2175Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3100Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3270Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3290Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-3050Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)2 reports
- RxSight Light Adjustable Lens (RxLAL) 60005-2110Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)1 report
- RxSight Light Adjustable Lens (RxLAL) 60005-2120Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)1 report
- RxSight Light Adjustable Lens (RxLAL) 60005-2235Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)1 report
- RxSight Light Adjustable Lens (RxLAL) 60005-2280Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)1 report
- RxSight Light Adjustable Lens (RxLAL) 60005-2290Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)1 report
- RxSight Light Adjustable Lens (RxLAL) 60005-3280Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)1 report
Recent RxSight Light Adjustable Lens (RxLAL) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 50916564 ↗InjurySep 23, 2026Detachment of Device or Device Component
A site reported to RxSight that upon implantation of a Light Adjustable Lens (LAL), it was noted the leading haptic had become severed. While attempting to remove the LAL, both haptics detached from the optic, resulting in the surgeon using intraocular scissors to section the lens to facilitate removal. A posterior capsular tear occurred during lens removal, requiring a vitrectomy. A replacement LAL was subsequently implanted successfully in the sulcus. Although a dispersive OVD was used intraoperatively to protect the corneal endothelium, the surgeon reported at the two-week postoperative visit that significant corneal edema persisted and expressed concern that endothelial compromise had occurred, potentially requiring future endothelial transplantation.
Patient problems: Capsular Bag Tear; Corneal Edema; Corneal Endothelial Cell Loss
MAUDE report 50868490 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
A site reported to RxSight that a patient's Light Adjustable Lens (LAL) was explanted from the left eye due to patient dissatisfaction with visual acuity and dysphotopsia. Prior to lens explant, the patient completed all necessary light treatments targeting near vision for the left eye. A replacement Light Adjustable Lens (LAL) was implanted without complications.
Patient problems: Visual Disturbances
MAUDE report 50839854 ↗InjurySep 19, 2026Insufficient Device Problem Information
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 50831677 ↗InjurySep 18, 2026Optical Problem
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 50826758 ↗InjurySep 18, 2026Optical Decentration
A site reported to RxSight that a patient's Light Adjustable Lens (LAL) was observed to be dislocated during a post-operative exam. An anterior vitrectomy was performed and the LAL was successfully repositioned in the sulcus during a secondary surgery.
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 50820389 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
A site reported to RxSight that a patient's Light Adjustable Lens (LAL) was explanted from the right eye (OD) due to blurred distance vision. Another LAL was implanted as a replacement.
Patient problems: Blurred Vision
MAUDE report 50818350 ↗InjurySep 17, 2026Optical Decentration
A site reported to RxSight that a patient presented to the clinic with complaints of shadowing. During postoperative examination, the Light Adjustable Lens (LAL) was observed to be decentered. It was subsequently noted that one haptic was positioned in the sulcus rather than within the capsular bag. A secondary surgical procedure was performed, during which the lens was successfully repositioned. No additional information has been provided.
Patient problems: Visual Disturbances
MAUDE report 50807904 ↗InjurySep 16, 2026Optical Problem
A site reported to RxSight that after a patient's Light Adjustable Lens (LAL) was implanted, the patient underwent 3 light adjustments and 1 Lock-in treatment postoperatively. The patient returned to the clinic approximately 3 years after implantation and a slit lamp exam found evidence of a suspected central distortion that is consistent with photopolymerization. A fourth light adjustment and second Lock-in were then performed. The LAL was subsequently explanted and a vitrectomy was performed before a new LAL was implanted as a replacement.
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 50790249 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
A site reported to RxSight that during implantation of a Light Adjustable Lens (LAL), a posterior capsule tear occurred during injection of the LAL, and an anterior vitrectomy was performed. The physician subsequently examined the patient and reported that the patient was doing well with no retinal issues on examination.
Patient problems: Capsular Bag Tear
MAUDE report 50773358 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 50262373 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
A site reported a capsular tear during implantation of a Light Adjustable Lens (LAL). The lens was successfully implanted in the sulcus. No additional information has been provided.
Patient problems: Capsular Bag Tear
MAUDE report 50235564 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
A site reported to RxSight that a bilaterally implanted patient's Light Adjustable Lens was explanted from the left eye due to a shift in refraction and monocular diplopia after completion of light treatments. A new LAL was implanted as a replacement. No additional information is available.
Patient problems: Diplopia/Double Vision; Visual Impairment
MAUDE report 50212626 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
A site reported to RxSight that a bilaterally implanted patient's Light Adjustable Lens was explanted from the right eye due to a shift in refraction and monocular diplopia after completion of light treatments. A new LAL was implanted as a replacement. Postoperatively, the site reported that the patient was satisfied with the results of the lens exchange and that the diplopia in the right eye was resolved.
Patient problems: Diplopia/Double Vision; Visual Impairment
MAUDE report 50212624 ↗InjuryAug 10, 2026Optical Problem
A site reported to RxSight that a bilaterally implanted patient's Light Adjustable Lens (LAL) was explanted from the left eye due to poor quality of vision despite a best-corrected distance vision of 20/20. Additionally, the physician described the lens appearance as "hazy". A new LAL was implanted as a replacement. No additional information has been provided.
Patient problems: Blurred Vision
MAUDE report 50193888 ↗
Other Rxsight, Inc. products
All Rxsight, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page