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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgical images were reviewed.The eye was well centered and stable during the docking procedure.There was a corneal opacity that interrupted a portion of the capsulotomy, but it is unclear whether it contributed to the anterior tear as it was approximately 90 degrees away from the point of the tear.Unable to determine what contributed to this event.No surgical intervention was required.
Event or Problem Description
On 10/3/2019, lensar (b)(4) reported the following from a (b)(6) 2019 case day: "while on-site, the doctor reported that he had a patient that resulted in a double-cut (wisp) near one intelli-l mark, and an anterior tear at the other mark location.The patient was implanted with the originally intended iol, and there were no complications.No surgical intervention was required.

• 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: 9269017
• Report Number: 3009026057-2019-00010
• Device Sequence Number: 16659929
• Product Code: OOE
• UDI-Device Identifier: 00867744000112
• UDI-Public: 010086774400011211190515
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

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: 10/03/2019
• Initial Report FDA Received Date: 11/01/2019
• 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: 70 YR