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	Capsular Bag Tear (2639)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
P1008 - clinical outcome - issue: on (b)(6) 2022, dr.(b)(6) (b)(4) reported to (b)(6) via email stating "my patient needed a toriciol, so i used lensar for the cap, 3-plane chop, and intelliaxis.The cap came off easily, and the intelliaxis nubs appeared normal.I did notice that the chop extended pretty deep so the pie pieces separated virtually to the capsule.After removing the 6 pieces of nucleus, i saw a clear lineposteriorly in cortex.I injected viscoat but couldn't tell whether the posterior capsule had ruptured.I proceeded to i/a the cortex and saw ananterior capsule rent emanating from the intelliaxis nub.I then realized that the rent had extended posteriorly.Needless to say, this was not much fun since the rent occurred with an eye full of cortex.But, using the vitrector i removed the cortex but had to bail on the toric lens since the lens needed sulcus fixation.".
Additional Manufacturer Narrative
Measure: this issue only impacted this specific device.Analyze: senior cas (b)(6) reviewed the open call for (b)(4): case (b)(6) - centration is good with minimal suction.Minor to major movement is noted throughout treatment.Cas (b)(6) spoke with surgeon and she believes that the laser was not the cause of the tear.The bag did not completely ruptured, so no vitreous leakage into the chamber.No surgical intervention needed.Root cause: patient movement contributed to possible double cuts to capsulotomy resulting in a weaken capsule area.Laser functioned as designed.Improve/innovate/control: stabilization of the patient's head to reduce movement.

• 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
• Manufacturer Contact: keith peck ; 2800 discovery drive ste. 100; orlando, FL 32826 ; 8885756412
• MDR Report Key: 15083274
• Report Number: 3009026057-2022-00020
• Device Sequence Number: 4034630
• Product Code: OOE
• UDI-Device Identifier: 10867744000119
• UDI-Public: (01)10867744000119(11)220223
• 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): 07/19/2022

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: 06/30/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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