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

Catalog Number N/A

Device Problems Misfocusing (1401); Device Dislodged or Dislocated (2923)

Patient Problems Irritation (1941); Pain (1994); Blurred Vision (2137); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that an implantable collamer lens was implanted into the patient's left eye (os).Reportedly, pain due to rotation, shifting vault and iris irritation.Lens was rotated, this did not resolve the problem.Lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

B1 - corrected to adverse event in initial mdr.B2 - corrected to required intervention to prevent impairment/damage (devices) in initial mdr.H1 - corrected to serious injury in initial mdr.H6 - result code: 213 changed to result code: 114 in initial mdr.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
• MDR Report Key: 10332958
• MDR Text Key: 202212750
• Report Number: 2023826-2020-01569
• Device Sequence Number: 1
• Product Code: QCB
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2020

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention