MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number ASKU

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

Patient Problems Corneal Abrasion (1789); Glaucoma (1875); Intraocular Pressure Increased (1937); Retinal Tear (2050); Vitreous Hemorrhage (2143); Intraocular Pressure Decreased (4468)

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Literature article: "trim and excision technique by 10k/25g btp enhances intraoperative precision in mivs in day surgery for the treatment of pdr patients.Comparison of 10k/25g beveled-tip probe to 5k/23g flat-tip probe in ppv in day surgery for the treatment of pdr patients".The manufacturer internal reference number is: (b)(4).

Event Description

In literature study article, a non-healthcare professional reported that to investigate and compare the intraoperative precision of 10k/25-gauge (g) beveled-tip probe (btp) versus 5k/23-g flat-tip probe (ftp) vitrectomy conducted as day surgery for proliferative diabetic retinopathy (pdr).A total of one hundred seventy-three consecutive eyes of 173 pdr patients who underwent primary vitrectomy for pdr between (b)(6) 2023 were studied.All subjects received mivs (minimally invasive vitrectomy surgery) in day surgery by the same surgeon randomly using a 10k/25-g btp (study group) or a 5k/23-g ftp (control group) with the console and were followed up for three months.A total of 173 eyes(173 patients) were included in the study, and there was no statistical difference between the two groups in terms of pre-surgical general conditions.The post-surgical general conditions occurred were, the patients experienced iatrogenic retinal breaks, postoperative ocular hypertension, hypotony, serious vitreous hemorrhage, new vascular glaucoma, corneal epithelial damage.The current condition of the patients was unknown.

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19145808
• MDR Text Key: 340621135
• Report Number: 2028159-2024-00582
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK; CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other