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

Model Number TMICL12.6

Device Problems No Apparent Adverse Event (3189); Ejection Problem (4009)

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

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

Unk, unk, unk, unk, unk.Work order search: no similar complaint type events were reported for units within the same lot.Claim# 431171.

Event Description

The reporter indicated that on (b)(6) 2020 a tmicl12.6, -8.50/1.0/089 (sphere/cylinder/axis), implantable collamer lens "was hung up in plunger.Lens not implanted." cause of the event is reported as "lens got hung up in the plunger." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial, in liquid.Visual inspection found no visible damage to the lens.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: 10755787
• MDR Text Key: 213703037
• Report Number: 2023826-2020-02518
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542106634
• UDI-Public: 00841542106634
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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: 09/30/2020
• Device Model Number: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR