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

Model Number ICM120V4

Device Problems Material Opacification (1426); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cataract (1766); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the u.S.(b)(4).Claim#: (b)(4).

Event Description

The reporter indicated that a 12.0mm, icm120v4, -17.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) in 2003.Lens opacity (asc was observed on 15/oct/2020.Lens remains implanted.Cause of the event is reported as unknown.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

B5: the reporter indicated that a 12.0mm, icm120v4, -17.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) in 2003.Lens opacity (asc) was observed on (b)(6) 2020.The lens was exchanged for a lens of a different model with a longer length on (b)(6) 2020 which resolved the problem.Reportedly, the status of the eye is "all fine" and the patient is happy.The cause of the event is unknown.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• MDR Report Key: 11012227
• MDR Text Key: 221792211
• Report Number: 2023826-2020-03022
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 11/26/2020

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: 02/28/2005
• Device Model Number: ICM120V4
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR