MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS+ (LAL+)

Model Number	60007
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformances, or other manufacturing issues related to the reported event.Manufacturer reference #: (b)(4).
Event or Problem Description
A site reported that a patient presented during the postoperative period following implantation of a light adjustable lens+ (lal+) with a hyperopic refractive outcome of +7.50.Two light treatments were attempted to correct the refractive error without success.The patient had a history of prior radial keratotomy (rk) performed years before cataract extraction with intraocular lens implantation (ceiol).The treating physician reported that the prior rk incisions were deeper than typical and that keratometry values were extremely flat, ranging from approximately 20.00 to 23.00 diopters.Due to the degree of corneal flatness, the aberrometer was not able to accurately calculate the intraocular lens power and generated an incorrect recommended lens calculation based on a target manifest refraction spherical equivalent (mrse) of plano.An attempt was made to explant the lal+ due to the refractive outcome; however, explantation was not successful due to an unknown issue with the capsular bag.The treating physician plans to implant a secondary intraocular lens.No additional information is available.

• Brand Name: LIGHT ADJUSTABLE LENS+ (LAL+)
• Common Device Name: LIGHT ADJUSTABLE LENS+ (LAL+)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: jim zhang ; 100 columbia; aliso viejo, CA 92656 ; 9492736163
• MDR Report Key: 25035328
• Report Number: 3012712027-2026-00183
• Device Sequence Number: 9176247
• Product Code: PZK
• UDI-Device Identifier: 00818806021538
• UDI-Public: (01)00818806021538(11)241212(17)271130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60007
• Device Catalogue Number: 60007
• Device Lot Number: L08-007971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female