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

Model Number VTICM5_13.2

Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cataract (1766); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2020

Event Type  Death  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -9.5/+6.0/108 (sphere/cylinder/axis) into the patient's right (od) eye on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged with an alternate lens due to lens opacity-cortical.The cause of the event is reported as unknown.The surgeon states that the lens has a deposit on its surface.

Manufacturer Narrative

B5-final bcva 0.85, ucva 0.7.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

Additional information: this is a case of foreign debris on the lens that caused the exchange.Claim# (b)(4).

Manufacturer Narrative

H3: device evaluation: the lens was returned in liquid in a micro-centrifuge vial.There was residue/debris on the product.Visual inspection found no visible damage to the lens.And there was residue and debris on the lens surface.Red particulates were noted, on lens optic.Claim# (b)(4).

Manufacturer Narrative

13.2mm vticm5 13.2 implantable collamer lens; -9.5/+6.0/107.Claim# (b)(4).

Manufacturer Narrative

Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker ave.; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker ave; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12021862
• MDR Text Key: 264302929
• Report Number: 2023826-2021-02006
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/28/2021

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: 01/31/2023
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 06/15/2021; 08/05/2021; 08/30/2021; 10/22/2021; 12/21/2021
• Supplement Dates FDA Received: 07/11/2021; 08/27/2021; 09/23/2021; 11/12/2021; 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2020
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male