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	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Measure: this issue only impacts this device and does not impact any other fielded devices at this time.Analyze: cas, (b)(6) reviewed case #875.Centration placement is good with adequate suction to the eye.Minor patient movement was noted throughout.Frame #25 showed a 32 degree ak starting at an axis of 358 degrees.Ak was completed in frame # 33.Root cause: patient movement likely contributed to the poor localized imaging.Resulting in the corneal perforation.Laser functioned as design.
Event or Problem Description
Issue: on (b)(6) 2022, ((b)(4)) reported to (b)(6) that "dr.(b)(6) feels like his arcuate incision may have perforated and he would like the case reviewed." dr.(b)(6) sutured the ak and proceeded with no complications.

• 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: 15797280
• Report Number: 3009026057-2022-51553
• Device Sequence Number: 20002181
• Product Code: OOE
• UDI-Device Identifier: 00867744000112
• UDI-Public: 010086774400011211210106
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/14/2022

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: 10/21/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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