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

Model Number VICM5_12.6

Device Problems Misfocusing (1401); Off-Label Use (1494)

Patient Problems Endophthalmitis (1835); Red Eye(s) (2038); Uveitis (2122); Blurred Vision (2137)

Event Date 03/07/2023

Event Type  Injury  

Manufacturer Narrative

H6: health effect impact code: 4644 - predniline eye drops (6.5ml); vigamox 0.5% (5ml).H6: health impact - additional surgery: 4625 - a/c irrigation.(b)(4).H6 - 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 12.6mm vicm5_12.6 implantable collamer lens, -12.00 diopter, in the patients right eye (od), on (b)(6) 2023.The lens was removed on (b)(6) 2023 due to endophthalmitis was observed.Patient had red eye and blurred vision.Diagnostics were performed for uveitis and infection.Treatment was performed - a/c irrigation, prednilone eye drops (6.5ml) and vigamox 0.5% (5mil).The patient was treated and the eye has recovered.The lens was sent to a lab for bacterial culture test and and no present of bacteria was found on the lens.

Manufacturer Narrative

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 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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16725776
• MDR Text Key: 313188365
• Report Number: 2023826-2023-01250
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030016
• 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: 03/15/2023

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 Model Number: VICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2022
• 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 # 1585262.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # 1576116.
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male