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

Model Number VTICM5_12.6

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

Patient Problems Inflammation (1932); Iritis (1940); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Weight, ethnicity, race: unk.Date of event: unk.Pma/510k: this product is not marketed in the us.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated that a 12.6mm, vticm5_12.6, -11.5/2.5/100 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2021.The patient experienced excessive vault, pigment dispersion, unreactive (fixed) pupil, glare/haloes, inflammation and iritis.Lens remains implanted.It was reported that initially the doctor wanted to explant the lens but has decided to wait awhile.Medical intervention (pred forte, pilocarpine, prednisone) was prescribed.Cause of event was unknown.

Manufacturer Narrative

Corrected data: b5- correction: -11.50/2.5/100 should be corrected to -11.50/2.5/108 in the original medwatch report.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12763823
• MDR Text Key: 280521488
• Report Number: 2023826-2021-04230
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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: 05/31/2024
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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: INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male