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

Model Number VTICM5_13.7

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

Patient Problems Headache (1880); Intraocular Pressure Increased (1937); Vomiting (2144); No Code Available (3191)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a vticm5_13.7, -7.50/2.5/083 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.Excessive vault, significant reduction of irido-corneal angles and pigment dispersion were reported.The reporter also stated that "iris has been damaged at the limbal region, where you can see that the pigment layer has been dissolved." secondary surgical intervention (yag) was performed on post-op day 1 "because the condition of the eye and patient's rapport (headache and vomiting debuting ca 8 h after surgery) suggested that iop had been high." in the surgeons opinion the cause of the event was due to icl too large/ actual sulcus diameter smaller than expected from preop measurements.For patients' current condition the surgeon reported " patient is very pleased with the outcome, wears no lenses or glasses and would like to keep everything as it currently is; so close to emmetropia oa.However, there is rather large amounts of pigmentation on icl, iris atrophy and the vault is still ca 4 oa".The surgeon plans to remove the icl with no icl implantation." if additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

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 contribute to the complaint issue.Claim # (b)(4).

Manufacturer Narrative

Corrected data: h6- health effect clinical code 1937- intraocular pressure increase should be in the inital mdr.H6- investigation conclucions code 4310 should be in the previous mdr.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
• MDR Report Key: 9677189
• MDR Text Key: 178123194
• Report Number: 2023826-2020-00248
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2020

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: No Information
• Device Expiration Date: 03/31/2021
• Device Model Number: VTICM5_13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 04/14/2020; 10/28/2020
• Supplement Dates FDA Received: 06/05/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR