MAUDE Adverse Event Report: LENSAR, INC LENSAR LASER SYSTEM-FS 3D

Model Number	N/A
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgical images were reviewed and found the iris registration failed and a message was displayed to the doctor.In addition, it was found the icl was not removed before the surgical procedure.The icl changed the laser focus posteriorly approximately 1.0 mm.The last surgical frame that captures the completion of the capsulotomy, frame 9, showed that the capsulotomy was performed in the lens.The icl pushed the laser treatment posteriorly.The doctor performed a vitrectomy, the iol will be changed to a c loop type.Having an icl implanted would be a contraindication for surgery.
Event or Problem Description
On (b)(6) 2018, lensar representative reported that the doctor had a procedure in which the capsulotomy was made in the middle of the lens and the chop ablated on the posterior lens.According to the surgeon, the patient had icl(staar) in his eye and the surgeon removed icl from his eye to do a cataract surgery.According to the clinical application staff, the scan procedure was successful and iris registration failed.No message was showed during the surgery.
Additional Manufacturer Narrative
Surgical images were reviewed and found the iris registration failed and a message was displayed to the doctor.In addition, it was found the icl was not removed before the surgical procedure.The icl changed the laser focus posteriorly approximately 1.0 mm.The last surgical frame that captures the completion of the capsulotomy, frame 9, showed that the capsulotomy was performed in the lens.The icl pushed the laser treatment posteriorly.The doctor performed a vitrectomy, the iol will be changed to a c loop type.Having an icl implanted would be a contraindication for surgery.
Event or Problem Description
On 10/05/2018, lensar representative reported that the doctor had a procedure in which the capsulotomy was made in the middle of the lens and the chop ablated on the posterior lens.According to the surgeon, the patient had icl (staar) in his eye and the surgeon removed icl from his eye to do a cataract surgery.According to the clinical application staff, the scan procedure was successful and iris registration failed.No message was showed during the surgery.

• Brand Name: LENSAR LASER SYSTEM-FS 3D
• Common Device Name: LENSAR LASER SYSTEM-FS 3D
• Manufacturer (Section D): LENSAR, INC; 2800 discovery drive ste.100; orlando FL 32826
• MDR Report Key: 8023743
• Report Number: 3009026057-2018-00007
• Device Sequence Number: 2170245
• Product Code: OOE
• UDI-Device Identifier: 00867744000112
• UDI-Public: 010086774400011211180828
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K120214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: N/A
• Device Catalogue Number: 70-00013-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR