MAUDE Adverse Event Report: ALCON LABORATORIES, INC. - CIDRA MEMORY LENS U940S1; INTRAOCULAR LENS

Lot Number ASKU

Device Problems Calcified (1077); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

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 surgeon reported that following an intraocular lens (iol) implant procedure, dislocated iol was found in the eye.Exam found a dislocated lens bag complex with a calcified lens in the eye.Dislocation was posteriorly, swinging back and forth like a trap door.The iol was removed the lens in a secondary procedure.No further information is expected.

Manufacturer Narrative

The product was not returned for analysis.The product history records could not be reviewed because the documentation is not available.The lot indicated is company is not on the buffered tumbling lot list.The product investigation could not identify a root cause for the reported complaint.The lens was discarded.The surgeon provided the information that the product did not cause or contribute to the event.In the surgeon¿s opinion the event was due to loss of support/weak zonules.The manufacturer internal reference number is: (b)(4).

• Brand Name: MEMORY LENS U940S1
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES, INC. - CIDRA; km 1 hm 1 rr 173; cidra PR 00739
• Manufacturer (Section G): ALCON LABORATORIES, INC. - CIDRA; km 1 hm 1 rr 173; cidra PR 00739
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13934145
• MDR Text Key: 288087547
• Report Number: 1610287-2022-00020
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LUCIA 602 17.5
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 110 KG