MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number TMICL13.2

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

Patient Problems Intraocular Pressure Increased (1937); Iritis (1940)

Event Date 05/25/2022

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm tmicl13.2 implantable collamer lens of -16.50/1.5/089 (sphere/cylinder/axis) was implanted into the patient's eye.The lens was explanted due to iritis/iop elevation.Lens was not replaced.

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.(b)(4).

Manufacturer Narrative

H3: device evaluation: the lens was returned in liquid in a specimen cup.Visual inspection found no visible damage to the lens.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 15469467
• MDR Text Key: 300424380
• Report Number: 2023826-2022-03140
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542109932
• UDI-Public: 00841542109932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female