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

Model Number MICL 12.6

Device Problems Misfocusing (1401); Material Opacification (1426); Optical Problem (3001)

Patient Problems Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm micl12.6, -9.0 diopter, implantable collamer lens, into the patient's right eye (os) on (b)(6) 2016.Lens opacity (asc) was observed on (b)(6) 2019.Glare/haloes and blurred vision was also observed.Lens remains implanted.Reportedly, "halos since surgery, at night.Alphagan helped.

Manufacturer Narrative

Additional information: h6 type of investigation- analysis of production records 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.Corrected data: b3-date of event in initial mdr should be reported as (b)(6) 2018.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
• MDR Report Key: 10483350
• MDR Text Key: 207385380
• Report Number: 2023826-2020-01952
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103015
• UDI-Public: 00841542103015
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: MICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Patient Age: 38 YR