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 Corneal Clouding/Hazing (1878); Blurred Vision (2137)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -09.00/+3.0/093 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2021.Post-op, the vision was hm and there was significant corneal clouding.Lens looked appropriate and phakic lens was clear.The lens remained implanted.This was the replacement lens for mfr.Report # 2023826-2021-02534.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

B5 - the reporter indicated the surgeon implanted a 12.6mm lens in the patients left eye (os) on (b)(6) 2021.Reportedly post-op the vision was hm and there was significant corneal clouding.Lens looked appropriate and phakic lens was clear.The lens remains implanted.The serial number for this lens was not provided.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 12200502
• MDR Text Key: 262631603
• Report Number: 2023826-2021-02790
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542108911
• UDI-Public: 00841542108911
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2020
• 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: CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL AND LOT # UNK; CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL AND LOT # UNK
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female