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

Model Number VTICM5_13.2

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Weight, ethnicity, race: unk.This product is manufactured in the u.S.But not marketed in the u.S.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that, while implanting a 13.2mm vticm5_13.2 implantable collamer lens, -10.5/+2.0/083 (sphere/cylinder/axis) into the patient's left eye (os), it tore.It was removed intraoperatively and there was no patient injury.This occurred on (b)(6) 2019.The cause of the event is reported as user error and loading error; however the surgeon states that the lens was "delivered with the hole.".

Manufacturer Narrative

B5- previously stated this occurred on (b)(6) 2019.Corrected info: this occurred on (b)(6) 2019.Additional info: the lens was implanted, removed, and replaced all within the same surgery.The problem is resolved.H3-device evaluation: the lens was returned in a micro-centrifuge vial with moisture on the lens.Visual inspection found that the optic was torn.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).

Manufacturer Narrative

B5-updated information: a backup lens was implanted.Reportedly, "everything is o.K." claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9476272
• MDR Text Key: 178343488
• Report Number: 2023826-2019-02393
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2019

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: 01/31/2022
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 01/21/2020
• Supplement Dates FDA Received: 01/14/2020; 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Age: 31 YR