MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065740970
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample has been received by manufacturing that has not yet been evaluated.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 or Problem Description
A surgeon reported that during a cataract surgery the irrigation and aspiration tip exhibited a metal shard which resulted in a capsular tear.The surgery was completed with a three piece intra ocular lens.Additional information received indicated that the shard might be either metal or plastic located on the back side of the silicone tip.
Additional Manufacturer Narrative
One opened silicone irrigation/aspiration (ia) tip in a specimen container was received for the report of the slit in the capsule had metal shard found on the tip.The returned sample was visually inspected.The silicone irrigation/aspiration (sia) tip was found to be conforming for the report of a burr, but nonconforming for the silicone sleeve is rolled up in the back side with two strings of foreign material between the cannula and the silicone sleeve.The foreign material was sent to the particle lab for fourier transform infrared spectroscopy (ft-ir) evaluation determined the clear particle did not yield any good matches.The particle was then scanning electron microscopy/energy dispersive x-ray spectroscopy (sem/eds) analyzed and was identified as oxygen (o), magnesium (mg), aluminum (ai), silicon (si) and calcium (ca).The exact identity of the clear particle in unknown, however the foreign material had a high concentration of silicone.Per the qe the, sia tip and sleeve were visually inspected for damage/missing piece of silicone.Both the sia tip and sleeve were conforming.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The complaint evaluation doesn't confirm burrs or a metal shard on the tip as described in the complaint and a root cause cannot be determined for the complaint as described by the customer.Unrelated to the reported event, foreign material was confirmed on the sia tip distal od under the silicone sleeve.The particle analysis found the exact identity to be unknown, however the foreign material had a high concentration of silicone.Both the sia tip and silicone sleeve were found to be conforming for any damage; therefore how and when the foreign material became present on the sia tip cannot be determined from this evaluation and a root cause cannot be determined.The sia tip cannula was found to be conforming for a burr and no specific action with regard to this complaint was taken because the root cause for the foreign material cannot be determined from this evaluation.All silicone i/a tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing 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 further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: SILICONE IRRIGATION AND ASPIRATION TIPS
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• 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: 12619757
• Report Number: 2523835-2021-00385
• Device Sequence Number: 1478745
• Product Code: KYG
• UDI-Device Identifier: 00380657409709
• UDI-Public: 00380657409709
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065740970
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CENTURION SURGICAL
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown