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

Model Number	60005
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	06/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a sulcus-placed light adjustable lens (lal) was observed to be decentered at the one-day postoperative follow-up.During the initial implant procedure, the patient first underwent explantation of a previously implanted non-rxsight intraocular lens (iol).During removal of the non-rxsight iol, the physician created a scleral tunnel and encountered difficulty freeing one edge of the lens.The physician subsequently suspected that a noted capsular bag tear may have occurred during manipulation of the non-rxsight iol.Following removal of the prior lens, the lal was implanted in the sulcus to achieve optic capture.Per reported information, no apparent defects or issues were noted on the lal prior to use, the lal was loaded into the injector correctly, and the lal was delivered successfully with no noted haptic deformation or deployment issues.After the lal was observed to be decentered at the one-day follow-up, the physician performed a secondary surgical procedure the same day to reposition the lal but noted intraoperatively that one haptic appeared as if it had not expanded.The physician attributed the lens decentration to the suspect haptic and as a result, the lal was explanted and replaced with a new lal.The replacement lal was reported to be well centered postoperatively, and no visual issues were reported by the patient.
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformances, or other manufacturing issues related to the reported event.The explanted lal was reportedly discarded by the clinic and therefore could not be evaluated.A photographic image of the explanted lal was provided and appears to show possible damage or deformation of one of the haptics.However, the exact nature of this possible haptic issue and how or when it occurred cannot be ascertained from the photograph.As a result, any relationship between haptic-related issues and the reported lens decentration cannot be established.It is possible that patient anatomical conditions following the difficult removal of the previous, non-rxsight iol may have contributed to the decentration of the lal.Manufacturer reference #: (b)(4).

• 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 ; 9492736163-159
• MDR Report Key: 25815871
• Report Number: 3012712027-2026-00316
• Device Sequence Number: 17633596
• Product Code: PZK
• UDI-Device Identifier: 10818806021016
• UDI-Public: 10818806021016
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 07/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-009988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RXSIGHT INSERTION DEVICE, MODEL 63002.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female