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

Model Number VTICM5_13.7

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Iritis (1940); Uveitis (2122)

Event Date 10/19/2021

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens, into the patients right eye (od) in (b)(6) 2021.At 6 months post-op, the lens was reported as having low vaulting which subsequently caused inflammation and acute anterior uveitis/ iritis had developed.One day after taking intensive topical steroids, the patients symptoms had improved dramatically.The lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

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

Manufacturer Narrative

The lens was a -12.00/+2.0/096 diopter.The patient was reported as doing well at last post-op visit.H6: work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

B5: the reporter indicated the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens, in the patient's right eye (od), in (b)(6) 2021.At 6 months post-op, the patient experienced inflammation and acute anterior uveitis/iritis.One day after taking intensive topical steroids, the patients symptoms had improved dramatically.The lens remained implanted.H6: medical device problem code: 2993.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: 12833486
• MDR Text Key: 280945818
• Report Number: 2023826-2021-04292
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: VTICM5_13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/23/2021; 01/17/2022
• Supplement Dates FDA Received: 12/23/2021; 01/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2021
• 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: CARTRIDGE MODEL SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-TF - LOT # UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male