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

Model Number VTICM5_13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intraocular Pressure Increased (1937); Pupillary Block (2026); Retinal Detachment (2047); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/03/2022

Event Type  Injury  

Manufacturer Narrative

Age at time of event, date of birth :unk.Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Model: expiration date unk.If implanted, give date: unk.If explanted, give date: unk.Device manufacture date: unk.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted an evo icl implantable collamer lens.The surgeon reported late postoperative pupillary block with fibrin occluding the pupil.The surgeon performed a pi, which resolved the high iop.Culture of the occlusion was negative and the patient did well.The lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Additional data: h6: health impact- clinical code: 4581 - unreactive (fixed) pupil.H6: health impact - additional surgery: 4625 -pars plane vitrectomy.H6: work order search: no similar complaint was reported for units within the same lot.Corrected data: b5: the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -11.50/+2.0/070 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2022.The surgeon reported late postoperative pupillary block, with elevated intraocular pressure (iop), unreactive (fixed) pupil and fibrin occluding the pupil.The surgeon enlarged the pi, which resolved the high iop.The patient had a retinal detachment macula on (b)(6) 2022, which required a pars plane vitrectomy surgery.Culture of the occlusion was negative and the patient did well.The lens remained implanted.D2: phakic toric intraocular lens, product code: qcb.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: 15990641
• MDR Text Key: 305582327
• Report Number: 2023826-2022-04529
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542116800
• UDI-Public: 00841542116800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2022

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_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2022
• 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: CARTRIDGE MODEL SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL AND LOT # UNK.; UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female