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

Model Number VICMO12.1

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problems Cyst(s) (1800); No Code Available (3191)

Event Date 04/02/2020

Event Type  Injury  

Manufacturer Narrative

Weight: unk, ethnicity: unk, race: unk.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 vicmo 12.1 implantable collamer lens, -13.00 diopter, in the patient's right eye (od) on (b)(6) 2019.The lens was explanted on (b)(6) 2020 due to patient had a ciliary cyst and the lens was in an eccentric position.The patient requested the lens be explanted.The cyst was pre-existing.The lens was out of position, the central hole of the lens was located in the lower half of the pupillary region.The surgeon does not plan to implant other icl lens.Cause of the event was unknown.

Manufacturer Narrative

Additional informatin: h3-device evaluation: lens returned dry in a micro-centrifuge vial with clear residue on product.Visual inspection found haptic bent and residue on lens.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: 10026180
• MDR Text Key: 189915398
• Report Number: 2023826-2020-01020
• Device Sequence Number: 1
• Product Code: MTA
• 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: 04/16/2020

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: 03/31/2022
• Device Model Number: VICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR