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

Model Number VTICMO13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Intraocular Pressure Decreased (4468)

Event Type  Injury  

Manufacturer Narrative

G4-pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.Investigation type 4110: 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 13.2mm vticmo13.2 implantable collamer lens, -9.5/+2.0/080 (sphere/cylinder/axis), into the patient's left eye (os) on (b)(6)2020.The surgeon reports a high vault of 1006um and an iop<5mmhg.However, because of hypotony and iris incision and after corneal suture, the vault is 720um.Reportedly, the lens remains implanted.The cause of the event is reported as unknown.

Manufacturer Narrative

H3: device evaluation: lens was returned in a vial in liquid with debris on the lens.Visual inspection found the haptic torn with foreign debris on the lens.Claim# (b)(4).

Manufacturer Narrative

Device history record- based on the results of the investigation all released devices from the associated work word(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue." should have been in the previous mdr.Claim# (b)(4).

Manufacturer Narrative

B5 - the reporter indicated that the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -9.5/+2.0/080(sphere/cylinder/axis), into the patient's left eye (os) on (b)(6) 2020.Excessive vault, iris prolapse and addition of suture, glare and haloes were observed.The lens was explanted on (b)(6) 2020.A lens of a shorter length was implanted on the same day and the problem was resolved.Reportedly, there were "no complaints" for the status of the eye.The cause of the event is reported as unknown.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 10556172
• MDR Text Key: 207605873
• Report Number: 2023826-2020-02123
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2020

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: 05/31/2023
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 04/09/2021; 08/10/2021; 12/03/2021
• Supplement Dates FDA Received: 05/06/2021; 09/01/2021; 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Required Intervention
• Patient Sex: Female