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

Model Number TMICL12.6

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The lens was returned in liquied, in a micro-centrifuge vial.Visual inspection found no visible damage to the lens; toric marks are light.Lens work order search-no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 lens, -13.0/2.0/090 (sphere/cylinder/axis) implantable collamer lens into the patient's eye.The lens was removed and replaced with a backup lens, the surgeon stating he could not see the toric marks on the lens.

Manufacturer Narrative

B5-additional information: the lens was implanted, removed, and replaced intraoperatively.H6-health impact code corrected h6-method code 3331, 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 TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11135964
• MDR Text Key: 225723276
• Report Number: 2023826-2021-00037
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542107280
• UDI-Public: 00841542107280
• 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: 12/09/2020

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-1502316; FOAM TIP PLUNGER MODEL-FTP, LOT#-1471717; INJECTOR MODEL-MSI-PF, LOT#-1442890
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR