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

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
P1008 - posterior capsule tear - issue: on 03/20/2023 while on site, (lls5124) there was a posterior capsule tear on last quadrant of cataract removed during procedure id 715.
Additional Manufacturer Narrative
Measure: this issue only impacted this specific device.Analyze: cas, jessica byer reviewed the open call for lls5124: case #715- centration was good with suction holding throughout the procedure.Minimal patient movement is noted throughout.Capsulotomy begins in frame #3 with full breakthrough in frame #7.Lens fragmentation begins in frame # 13 and completed in frame #27.Both capsulotomy and lens fragmentation were completed without issue.Root cause: minor patient eye movement could contribute to a weakened treatment to the capsulotomy.Surgical techniques could cause additional stress to capsulotomy with incision placement.Laser functioned as designed.Patient required mo additional treatment and is doing well post operatively.

• 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
• Manufacturer (Section G): LENSAR, INC; 2800 discovery drive ste. 100; orlando FL 32826
• MDR Report Key: 16751844
• Report Number: 3009026057-2023-54387
• Device Sequence Number: 18299351
• Product Code: OOE
• UDI-Device Identifier: 10867744000119
• UDI-Public: (01)10867744000119(11)201023
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K182795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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 Sex: Unknown