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

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient suffered from uncontrollable rise of intraocular pressure (iop) after selective laser trabeculoplasty (slt) treatment.While a transient iop rise is a common side effect, this specific patient needed an increase of medication (from one drug to two) due to insufficient iop control after the spike.Three months after laser treatment this patient needed a surgery because of uncontrolled iop and inability for further increase of topical medication due to multiple drugs intolerances.The surgery performed was an uneventful phaco-migs.The iop at six months laser treatment follow up was 12 mm hg (baseline iop of 29 mmhg).
Additional Manufacturer Narrative
According to the instruction for use, the device slt function of the device is intended only for primary open-angle glaucoma.In this case, the user treated pexg patients with slt function which represents an off-label use.In general, the instruction for use lists ocular hypertension under side effects of slt.A device analysis is not necessary since this is a user error, and no device malfunction was reported.

• 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: 20311563
• Report Number: 9615030-2024-00017
• Device Sequence Number: 8686462
• Product Code: HQF
• UDI-Device Identifier: 04049471091441
• UDI-Public: (01)04049471091441(11)200701
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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 Model Number: N/A
• Device Catalogue Number: 000000-2247-917
• 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: 09/03/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• 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 Sex: Unknown