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

Model Number VICMO 13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Headache (1880); Pain (1994); Red Eye(s) (2038); No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.This product is not marketed in the us.(b)(4).Work order search: one similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicmo 13.2, -07.00 diopter, implantable collamer lens into the patient's left eye (os) on (b)(6) 2019.Reportedly, patient "had red left eye with pain and headaches.Slit lamp examination showed exudation of anterior chamber, the surgeon washed the anterior chamber and removed the lens on (b)(6) 2019.An anti-inflammatory therapy was taken.Bacterial culture showed positive (anterior chamber aqueous humor).Now the patient is in good condition and his visual acuity has recovered to pre-operative ucva and bcva in the last visit." cause of event is reported as unknown.

Manufacturer Narrative

B5 - 'antibiotics (cerfuroxime) were prescribed as treatment.' should have been included in initial mdr.H6 - patient code 3191 should have been included in initial mdr.H6 - patient code 3191: medical intervention - antibiotic treatment (cefuroxime), anterior chamber washout should have been included in initial mdr.Claim# (b)(4).

Manufacturer Narrative

Device evaluation: lens returned in a microcentrifuge vial with moisture on lens.Visual inpection found haptic torn.Method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established 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
• MDR Report Key: 9483580
• MDR Text Key: 174176222
• Report Number: 2023826-2019-02411
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 11/29/2019

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: 10/31/2021
• Device Model Number: VICMO 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/14/2020; 02/28/2020
• Supplement Dates FDA Received: 02/03/2020; 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#1433081; FOAMTIPPLUNGER MODEL#FTP,LOT#1429576; INJECTOR MODEL#MSI-PF,LOT#1413851
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR