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

Model Number VICM5 13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Eye Injury (1845); Blurred Vision (2137)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

Weight: unk, ethnicity: unk, race: unk.This product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated that a 13.2mm, vicm5_13.2, -11.00 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2021.Excessive vault , transient loss of bcva, and bleeding on the back of the icl was observed.Medical intervention was prescribed (linderon 0.1%, eye drops 7 to 8 times, adna tablets 30 mg taken 3 times).It was reported that the problem resolved.For additional information the reporter stated " according to patient comments, after waking up on apr 19, her vision appeared to be veiled, but the symptoms disappeared two hours later.After that, her eyesight became hard to see from the evening".It was reported that there are no plans to replace the lenses because there is no problem with the eyesight.Cause of event was unknown " doctors suspect that the patient suffered a bruise while sleeping.".

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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
• MDR Report Key: 12104313
• MDR Text Key: 262885418
• Report Number: 2023826-2021-02224
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2021

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: 07/31/2021
• Device Model Number: VICM5 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR