MAUDE Adverse Event Report: SIGHT SCIENCES, INC. OMNI SURGICAL SYSTEM; PUMP, INFUSION, OPHTHALMIC

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

Patient Problems Hyphema (1911); Intraocular Pressure, Delayed, Uncontrolled (1936); Retinal Injury (2048); Visual Impairment (2138)

Event Type  Injury  

Event Description

A (b)(6) year old male patient underwent 180 degree viscodilation of schlemm's canal and 180 degree trabeculotomy using the omni surgical system in conjunction with cataract extraction and toric lens implantation in the right eye.The patient was reported to have moderate primary open angle glaucoma controlled on latanoprost.The surgery was uneventful.Routine post cataract management was provided (predmoxi 1%, 1 gtt qid for 15 days and prolensa 0.07%, 1 gtt tid for 7 days).On postop day 1, the intraocular pressure (iop) was fluctuating between 0 to 2, the eye was soft with evident corneal folds.The surgeon suspected a cyclodialysis cleft.In addition, a grade 1 layered hyphema was noted.The patient was kept under observation and was brought back for follow up on day 5.On postop day 5, the iop was between 2 and 4 with uncorrected visual acuity of 200/100 and corrected va of 20/50.The patient had descemet's folds.The surgeon confirmed that it was a cyclodialysis cleft.The hyphema was mildly resolved.No additional intervention was added.On postop day 10, all the signs were "as is" including visual acuity.Peripheral choroidal effusion was noticed and the patient was referred to a glaucoma specialist.All other medications were discontinued and the patient was put on cycloplegics.The patient was kept under observation and the healing of cyclodialysis was monitored.On august 7, 2020, the glaucoma specialist reported that the patient is completely recovered.The patient is on no medications with an iop of 9 mmhg, clear cornea, no positive posterior chamber findings and uncorrected va of 20/30.

• Brand Name: OMNI SURGICAL SYSTEM
• Type of Device: PUMP, INFUSION, OPHTHALMIC
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; ca
• Manufacturer (Section G): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park, ca
• Manufacturer Contact: edward sinclair ; 4040 campbell ave.; suite 100; menlo park, ca ; 2661144
• MDR Report Key: 10399198
• MDR Text Key: 203101890
• Report Number: 3010363671-2020-00003
• Device Sequence Number: 1
• Product Code: MRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• 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): Required Intervention
• Patient Age: 67 YR