MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION ULTRAVIT PROBE; VITRECTOMY, INSTRUMENT CUTTER

Catalog Number	8065750950
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Vitreous Hemorrhage (2143); Intraocular Pressure Decreased (4468)
Type of Reportable Event	Serious Injury
Additional 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.Comparison of 27-gauge beveled-tip and 25-gauge flat-tip microincision vitrectomy surgery in the treatment of proliferative diabetic ret inopathy.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
In literature study article, a non-health professional reported that to compare the effectiveness and safety of a 27-gauge (27g) beveled-tip vitrectomy probe in microincision vitrectomy surgery (mivs) with a conventional 25-gauge (25g) vitrectomy probe for the treatment of serious proliferative diabetic retinopathy (pdr).Fifty-two patients who were definitively diagnosed with pdr and required vitrectomy to remove the proliferative membrane.The primary outcome measure was the productivity of cutting the membrane throughout the operation.The important secondary outcome measures were the number of vitrectomy probes (vps) switched to micro forceps, intraoperative and postoperative complications, postoperative best-corrected visual acuity (bcva) and preoperative intraocular pressure (iop) of patients during the 6-month follow-up period.Compared with the 25g flat-tip vitrectomy probe, the 27g beveled-tip vitrectomy probe contributes to removing the proliferative membrane more efficiently and easily.It also reduced the occurrence of intraoperative hemorrhages and thus avoided excessive electrocoagulation.In terms of treatment outcome, the advanced bevel-tip vitrectomy probe is as effective and safe as the traditional 25g flat-tip vitrectomy probe.Hemorrhage recrudesced throughout the entire follow-up period.Three eyes in the 27g group and two eyes in the 25g group underwent vitreous cavity lavage, and their postoperative visual acuity was significantly improved.The others were treated with medication, and it was found that the hematocele was gradually absorbed.Similarly, ocular hypertension (>25 mmhg) and hypotension (<6.5 mmhg) appeared in both groups at different time points.Most patients with an elevated intraocular pressure (iop) used eye drops to restore normal pressure.There was no significant difference in the incidence of all the above complications between the groups.This case was one of two reports.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained; therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION ULTRAVIT PROBE
• Common Device Name: VITRECTOMY, INSTRUMENT CUTTER
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17450596
• Report Number: 1644019-2023-00983
• Device Sequence Number: 12577931
• Product Code: MLZ
• UDI-Device Identifier: 00380657509508
• UDI-Public: 00380657509508
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065750950
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown