MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISULAS GREEN; LASER, OPHTHALMIC

Catalog Number	000000-2096-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The described increase in iop after slt is a known side effect.There is no allegation of a device malfunction.
Event or Problem Description
It was reported that a primary open-angle glaucoma (poag) patient suffered from a persisting increase in intraocular pressure (iop) after selective laser trabeculoplasty (slt) treatment.It was further reported that the number of glaucoma medications had to be increased from 2 to 3.

• Brand Name: VISULAS GREEN
• Common Device Name: LASER, OPHTHALMIC
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: manjaya manjaya ; 5300 central parkway; dublin, CA 94568 ; 9255574259
• MDR Report Key: 20526971
• Report Number: 9615030-2024-00021
• Device Sequence Number: 21111526
• Product Code: HQF
• UDI-Device Identifier: 04049471091441
• UDI-Public: (01)04049471091441(11)011120
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K181682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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 Catalogue Number: 000000-2096-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female