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

Model Number VTICMO12.1

Device Problems Misfocusing (1401); Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Inflammation (1932); Red Eye(s) (2038); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon implanted a 12.1mm vticmo12.1 implantable collamer lens, -12.00/+2.0/062 (sphere/cylinder/axis), in the patients right eye (od), on (b)(6) 2020.On the 9th day after surgery, the patient complained of mild redness, a little photophobia, mild ciliary hyperemia, and a few plankton cells in anterior chamber.Medication was prescribed.On 10th day, visual acuity was slightly decreased and planktonic cells had increased from previous day.Some little fibrous membrane exudate on surface of lens.The lens was explanted on (b)(6) 2020.The lens and aqueous humor were sent for testing and the bacterial culture testing result was negative.Medication was prescribed, the inflammation has disappeared.The patient status is stable.The cause of the event was unknown.

Manufacturer Narrative

B5 - it was later reported that the patient experienced endophthalmitis.Also on (b)(6) 2021 a replacement lens of the same model/length but different power was implanted and the problem was resolved.Patient's visual acuity has recovered to pre operative ucva and bcva in the last visit.Claim#: (b)(4).

Manufacturer Narrative

Additional information: h6 - type of investigation 3331 - 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 91016
• MDR Report Key: 11092007
• MDR Text Key: 224249318
• Report Number: 2023826-2020-03236
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA#S-P#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,Followup
• Report Date: 12/04/2020

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: 11/30/2022
• Device Model Number: VTICMO12.1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 04/13/2021; 07/08/2021
• Supplement Dates FDA Received: 04/15/2021; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # 1423579; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR