MAUDE Adverse Event Report: SIGHT SCIENCES, INC. OMNI GLAUCOMA TREATMENT SYSTEM; VISCOELASTIC INJECTOR

Model Number 1-101

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

Patient Problems Corneal Edema (1791); Hypopyon (1913); Inflammation (1932); Intraocular Pressure Increased (1937); Visual Impairment (2138)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the facility and is not available for evaluation.Device did not provide lot number of device used.Mfr reference #: (b)(4).

Event Description

On (b)(6) 2018, the surgeon performed vasodilation and trabeculotomy with the omni device on the patient's right eye.The surgeon then performed phacoemulsification and insertion of an intraocular lens.The surgeon administered intracameral cefuroxime 1mg/0.1ml at the end of the procedure.There were no intraoperative complications.On (b)(6) 2018, the patient was diagnosed with mild-moderate corneal edema, iop elevation (28mhg), anterior chamber inflammation, hypopyon, and mild pain which was diagnosed as toxic anterior segment syndrome (tass).Patient's best corrected visual acuity had decreased from 0.4 pre-operatively to 0.2 at the onset of the event.No cultures were obtained.The patient was treated with topical cycloplegic drops (10 mg/ml of cyclopentolate hydrocloride) and azara (10 mg/ml plus 5 mg/ml of brinzolamide, timolol maleate).The event was resolved by (b)(6) 2018.The patient's iop has improved to 14 mmhg and the best corrected visual acuity has improved to 0.7.No other cases of tass or endophthalmitis were reported at the facility around the time of the event.The surgeon did not believe the omni device was the cause or a contributing factor in this event.

• Brand Name: OMNI GLAUCOMA TREATMENT SYSTEM
• Type of Device: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• Manufacturer Contact: anne-marie ripley ; 3000 sand hill rd., 3-105; menlo park, CA 94025 ; 6616458546
• MDR Report Key: 7747644
• MDR Text Key: 115955747
• Report Number: 3010363671-2018-00001
• Device Sequence Number: 1
• Product Code: MRH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K173332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1-101
• Device Catalogue Number: 1-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR