MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE PHACO TIP; UNIT, PHACOFRAGMENTATION

Catalog Number ASKU

Device Problem Particulates (1451)

Patient Problems Endophthalmitis (1835); Inflammation (1932)

Event Date 05/19/2022

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 pharmacist reported foreign body was found in the eye of a patient one month post cataract procedure.The patient experienced post operative inflammation.

Event Description

Additional information received from the surgeon who confirmed the patient experienced ocular damage, panuveitis which was further confirmed to be endophthalmitis caused by the foreign body in the right eye.The patient was hospitalized on an unknown date.The foreign body was not visible during the procedure, observed post operatively and was removed during capsular bag wash with vancomycin.The particle was gray in color, 1 millimeter (mm) in size and could be seen in naked eye post-operatively.The patient was treated with dexamethasone, apraclonidine and hyaluronic acid (eye drops).The patient was also treated with intravitreal injection of antibiotic and bacteriological sampling.The event was resolved with the treatment.

Manufacturer Narrative

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

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened plastic tray with foreign material in a bag was received.The foreign materials returned were sent to particle lab for analysis.The foreign materials were analyzed using micro ft-ir (micro-fourier transform infrared spectroscopy), the analysis indicates the best match off the yellow material to be poly(styrene acrynotrile ester) and the brown material finds the best match to be polyethylene.Poly(styrene acrynotrile ester) and polyethylene is also not associate with the phacoemulsification tip, the phacoemulsification tip manufacturing process or the phacoemulsification wrench material.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The photos were reviewed by the manufacturing site.The photos are of two trays, one having two black spots in the tray.The material composition or source could not be determined from the photo.The particle analysis found the foreign material to be poly(styrene acrynotrile ester) and polyethylene.The analysis of the materials are not used in the phacoemulsification manufacturing process, the packaging process of the phacoemulsification tip or phacoemulsification wrench material.How and when the poly(styrene acrynotrile ester) and polyethylene got into the eye of the patient cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.No specific action with regard to this complaint was taken because the source of the foreign materials is unknown.All phacoemulsification 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: PHACO TIP
• Type of Device: UNIT, PHACOFRAGMENTATION
• 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: 14752184
• MDR Text Key: 294510387
• Report Number: 2523835-2022-00228
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 09/26/2022; 10/24/2022
• Supplement Dates FDA Received: 07/21/2022; 09/26/2022; 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IOPIDINE (2 TIMES DAILY); TOBRADEX (4 TIMES DAILY); VISMED
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR
• Patient Sex: Female