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

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

Patient Problems Edema (1820); Intraocular Pressure Increased (1937); Visual Disturbances (2140); Halo (2227); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Age: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Product code: unk.Model #: unk.Device manufacturer date: unk.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a lens into patient's right eye (os) on (b)(6) 2019.Per reporter, "original vault day one was 700-800 with 1+ edema at one week with increasing vault to 1000-1200.Iops 23/22 at one-two hour visit, 21/21 at one week, 19/17 at one month." reportedly patients vision is 20/20 but halos and vault 1100-1200 with reportedly mid-dilated, poorly reactive pupils are being observed.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: g4: in the initial mdr is corrected to 06-oct-2019.H6-patient code 1937 in initial mdr is not applicable.Patient code 2140 in initial mdr is not applicable.Additional information: h6-patient code 2227-"haloes".Claim# (b)(4).

Manufacturer Narrative

Corrected data: b4- in initial mdr date 07-oct-2019 corrected to 06-oct-2019.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: 9278988
• MDR Text Key: 165236239
• Report Number: 2023826-2019-01995
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 01/07/2020; 01/23/2020
• Supplement Dates FDA Received: 01/08/2020; 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR