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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Capsular Bag Tear (2639)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

Measure: this issue only impacted this specific device.Analyze: senior cas michael rosenbaum reviewed the open call for lls2253: case #12067 - second docking attempt performed with oval elliptical cup.Centration was good with minimal suction.Minor movement is noted throughout treatment.Capsulotomy markers are placed at 53 and 233-degrees.Capsulotomy treatment is started at frame #3 with temporal breakthrough seen at frame #6 and completion at frame #8.Minor eye movement shows double cutting at marker 233-degrees.Fragmentation treatment is concluded at frame #27 and double ak incisions are completed without incident.Root cause: patient eye movement contributed to weakened treatment to the capsulotomy.

Event Description

P1008 - capsule tear - issue: on (b)(6) 2022, dr.Floyd (lls2253) reported to steve filipowicz a capsule tear adjacent to the intelliaxis nub closest to her main incision.It was noticed after iol insertion on proc id (b)(4).No other surgical intervention was required.

• Brand Name: LENSAR LASER SYSTEM-FS 3D
• Type of Device: 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
• Manufacturer Contact: keith peck ; 2800 discovery drive ste. 100; orlando, FL 32826 ; 8885756412
• MDR Report Key: 15798315
• MDR Text Key: 303660043
• Report Number: 3009026057-2022-51839
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other