PZKClass IIIImplant
Light Adjustable Lens (lal) And Light Delivery Device (ldd)
Ophthalmic · 21 CFR 886.3600
The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error.
MDR events1,354All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances0All time
Recent MDR events
1,354 adverse event reports on file
- Light Adjustable Lens (LAL)Jul 31, 2026InjuryRxsight Inc.3012712027-2026-00350
- Light Adjustable Lens (LAL)Jul 31, 2026InjuryRxsight Inc.3012712027-2026-00344
- Light Adjustable Lens+ (LAL+)Jul 31, 2026InjuryRxsight Inc.3012712027-2026-00348
- Light Adjustable Lens (LAL)Jul 31, 2026InjuryRxsight Inc.3012712027-2026-00342
- Light Adjustable Lens+ (LAL+)Jul 27, 2026InjuryRxsight, Inc.3012712027-2026-00333
- Light Adjustable Lens (LAL)Jul 27, 2026InjuryRxsight, Inc.3012712027-2026-00330
- Light Adjustable Lens (LAL)Jul 27, 2026InjuryRxsight, Inc.3012712027-2026-00327
- Light Adjustable Lens+ (LAL+)Jul 27, 2026InjuryRxsight, Inc.3012712027-2026-00340
- Light Adjustable Lens (LAL)Jul 27, 2026InjuryRxsight Inc.3012712027-2026-00336
- Light Adjustable Lens+ (LAL+)Jul 27, 2026InjuryRxsight, Inc.3012712027-2026-00335
Event type breakdown
Injury1,349
Malfunction4
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
1 premarket approvals for this product code