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

Model Number ICM115V4

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Pt info: unk.Pma/510k: this product is manufactured in switzerland but not marketed in the u.S.Device code: 1494 - this lens model is contraindicated for patients with age less than that of 21 years.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 11.5mm icm115v4 implantable collamer lens, -18.00 diopter, into the patient's right eye (od), on (b)(6) 2008.The lens was reported as having low vaulting and remained implanted.Additional information has been requested but none has been forthcoming.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; hauptstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; hauptstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16078599
• MDR Text Key: 308450132
• Report Number: 2023826-2022-04756
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNK
• 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
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: ICM115V4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2008
• 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
• Patient Age: 32 YR
• Patient Sex: Female