MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC

Catalog Number	8065480120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Corneal Clouding/Hazing (1878)
Type of Reportable Event	Serious Injury
Event or Problem Description
A literature article revealed that while treating a patient before entering the anterior chamber, ophthalmic viscosurgical device was accidentally injected into the corneal stroma, leaving a 4mm opacity superonasal within 4 mm of the central cornea, on the first postoperative day vision improved and there was mild superior corneal edema, by weeks after surgery the visual acuity improved.The cannula used to inject viscoelastic may had contributed to the reported event.No further information expected due to unlikelihood.
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.Inadvertent intrastromal injection of ophthalmic viscoelastic.J aapos.2013 dec;17(6) page number 639-41.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information has been provided in e.1.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of the ophthalmic viscosurgical device was accidentally injected into the corneal stroma; 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 is available.Per the dfu, viscoat is to be injected after entering the anterior chamber of the eye.Therefore, the root cause is use error.The root cause was not related to a manufacturing issue.A review of the sample evaluation revealed viscoat was injected into the eye before entering the anterior chamber.The product dfu provides detailed instructions that viscoat is to be injected after entering the anterior chamber of the eye.All cannula assemblies manufactured on the acam are 100% inspected for foreign material by vision detection system and 100% functionally tested for air flow during the automated assembly process.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
• Common Device Name: CANNULA, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15898932
• Report Number: 2523835-2022-00441
• Device Sequence Number: 12030010
• Product Code: HMX
• UDI-Device Identifier: 00380654801209
• UDI-Public: 00380654801209
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065480120
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 12/28/2022; 03/10/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/23/2023; 04/05/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR
• Patient Sex: Female