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

Model Number VTICM5 12.6

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

Patient Problems Uveitis (2122); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

Clinical code: (b)(4):endophthalmitis health impact : 4644:minocin cap 50mg; prednisolone 5mg; axadin cap 150mg; vigamox eye drops 0.5%.Investigation type 4110: lens work order search-no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -10.0/3.0/096 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2022.Endophthalmitis was reported.Diagnostics wa performe 'uveitis'.Treatment was performed: minocin cap 50mg; prednisolone 5mg; axadin cap 150mg; vigamox eye drops 0.5%.On (b)(6) 2022 the lens was exchanged for a same model and size lens but different axis.The replacement lens resolved the problem."improvement in symptoms after replacement.".

Manufacturer Narrative

Additional information: b5: the reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -10.0/3.0/096 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6)2022.In the complaint questionnaire, the box marked endophthalmitis was ticked and the diagnostics performed was described as 'uveitis'.Later clarification from the reporter stated that endophthalmitis was not diagnosed nor was there any evidence of this.At this time, medical management in the form of antibiotics (topical and systemic) with systemic steroids with gastric protection was prescribed.Following this, the reporter noted a "significant improvement in symptoms".However subsequent communication stated that "inflammation occurred a week after when steroids discontinued".Three weeks post-implantation the lens was exchanged for a new lens of same parameters which resolved the issue.H65: clinical code: 4581:endophthalmitis is not applicable.Claim#: (b)(4).

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 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: 15849035
• MDR Text Key: 304173375
• Report Number: 2023826-2022-04266
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 10/27/2022

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 01/31/2023; 04/17/2023
• Supplement Dates FDA Received: 02/13/2023; 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Sex: Female