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

Model Number VTICM5_12.6

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

Patient Problems Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/29/2022

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -14.00/+1.0/090 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2022.The lens was removed on (b)(6) 2022 due to excessive vaulting, elevated intraocular pressure (iop), pupil block, angle closure, unreactive (fixed) pupil and iris atrophy.An additional pi was performed on (b)(6) 2022 and there was anterior chamber irrigation/evacuation of visco/fluids.The lens was replaced with a shorter lens but the problem was not resolved.See mfr.Report # 2023826-2023-00099 for replacement lens.Remaining pupil dissipation after an acute glaucoma attack.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

(b)(4).Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

H3: device evaluation - lens was returned in microcentrifuge vial dry.Visual inspection found haptic broken.Unable to perform dimensional inspection due to signficant lens haptic damage.H6: 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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16142929
• MDR Text Key: 307150864
• Report Number: 2023826-2023-00098
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030016
• 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
• Report Date: 12/14/2022

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 Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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: 26 YR
• Patient Sex: Male