MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number AS71057-01

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

Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Uveitis (2122); Blurred Vision (2137)

Event Date 07/23/2021

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that a patient experienced postoperative endophthalmitis after the procedure.The patients current condition is unknown.Additional information was requested; however, none has been received to date.

Event Description

Additional information was provided by the surgeon who indicated the patient had undergone a femtosecond laser-assisted cataract procedure on the left eye.Three days postoperatively, the patient presented with decreased vision.The vision had decreased to hand motion (hm) at one foot, the anterior chamber had cells and fibrin present.The patient was referred to a retinal specialist who performed a vitrectomy, anterior chamber debridement, with intra-vitreal antibiotics injections.A culture was taken and was positive for staphylococcus epidermidis [staph epi].Twenty-one days postoperatively from the initial procedure, the surgeon indicated the patient's vision improved to 20/40, the eye demonstrated mild corneal edema and the patient's current condition was improving.The surgeon indicated the manufacturer's product(s) did not cause or contributed to the event.

Manufacturer Narrative

Additional information provided in a.1., a.2., a.3., b.2., b.3., b.5., b.6., d.10., h.6., and h.10.Following submission of the initial report, the reported event is no longer reportable as the surgeon indicated he is not blaming our product.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Correction provided in h.10.Additional information provided in b.2.And e.1.In the previously submitted supplemental medical device report.The manufacturer internal reference number is: (b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 12318585
• MDR Text Key: 266403418
• Report Number: 1644019-2021-00533
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS71057-01
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION WITH EPINEPHRINE; BALANCED SALT SOLUTION WITH OMIDRIA; INTRACAMERAL LIDOCAINE; TFNT30 INTRAOCULAR LENS IMPLANT; TOPICAL POVIDONE IODINE10%
• Patient Outcome(s): Other
• Patient Age: 73 YR