MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number ASKU

Device Problems Microbial Contamination of Device (2303); Device Operates Differently Than Expected (2913)

Patient Problems Corneal Edema (1791); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation per this literature article.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.Additional information has been requested.This is the second of two reports from this literature article.(b)(4).

Event Description

In a literature report it was indicated that viscoelastic products were used during an intraocular lens (iol) insertion when an audible crunching sound was heard.White granular material was noted on the lens and in the anterior chamber.The material was partially removed with irrigation.The lens was cut in half and removed from the eye.The remaining white material was retrieved through vigorous aspiration and irrigation.Some of the material could not be completely removed from the wound.Another lens was then implanted successfully.The wound was hydrated with balanced saline solution, subconjunctival antibiotics were injected and sodium chloride ointment was placed in the eye.The patient received an antibiotic injection was also given oral antibiotics for 10 days postoperatively.The patient developed corneal edema postoperatively at one week that resolved at one month.Half of the lens was sent for culture and the other half was sent for further analysis.Of the part of the lens sent for culture, the result was that the lens and cartridge grew bacillus species.Additional information was requested.

• Brand Name: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer (Section G): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6100696
• MDR Text Key: 59838309
• Report Number: 3002037047-2016-00183
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• 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
• Treatment: BSS; CEFAZOLIN; CLINDAMYCIN; LEVOFLOXACIN (ORAL AND INJECTION); MURO 128; VANNAS SCISSORS
• Patient Outcome(s): Other
• Patient Age: 65 YR