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

Model Number VTICM5_12.1

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Vitrectomy (2643); No Code Available (3191)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Work order search: no similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vticm5_12.1 implantable collamer lens, -11.50/+6.0/089 (sphere/cylinder/axis), in the patient's right eye (od), on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to the development of endophthalmitis.Diagnostic tests were performed which found serratia.A vitrectomy was performed and patient was administered intraocular injection.The lens was discarded.The patient did not return to the clinic but went to a hospital, where the lens was explanted, after tests and treatment.Currently, the inflammatory reaction was weaken and the patient's condition is improving.

Manufacturer Narrative

H6 - device code: 1494 - this lens model is contraindicated for patients with age less than that of 21 years.H6: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device; have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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
• MDR Report Key: 9772189
• MDR Text Key: 181478939
• Report Number: 2023826-2020-00389
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: VTICM5_12.1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR