MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

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

Patient Problems Rupture (2208); Capsular Bag Tear (2639)

Event Date 12/17/2020

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.(b)(4).

Event Description

A physician reported that during the polishing mode of a cataract extraction procedure the capsule was slightly pinched and ruptured.Procedure details have not bee provided.A completed questionnaire was received indicating the surgeon had difficulty going into the polish phase of a combined cataract/vitrectomy procedure.The patient experienced a posterior capsule tear centrally located.There was no shallowing of the anterior chamber, no occlusion.Vitreous did not present into the anterior chamber.The intraocular lens was inserted into the capsular bag.The patient did not require additional surgical or medical treatment.The patient was not hospitalized.The patient's symptoms have resolved without treatment.

Manufacturer Narrative

No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.A root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11147921
• MDR Text Key: 226056591
• Report Number: 2028159-2021-00042
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KSSP INTRAOCULAR LENS; KSSP INTRAOCULAR LENS
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 70