MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT; IMPLANT EYE VALVE

Model Number UNK-GLAUCOMA SHUNT

Device Problems Complete Blockage (1094); Device Dislodged or Dislocated (2923)

Patient Problems Wound Dehiscence (1154); Corneal Decompensation (1790); Hyphema (1911); Visual Impairment (2138); Loss of Vision (2139); Vitreous Hemorrhage (2143); Intraocular Pressure Decreased (4468)

Event Date 09/29/2022

Event Type  Injury  

Event Description

The following article was received based on a literature review: article: comparing surgical and clinical success rates of ahmed fp7, and baerveldt 250 and baerveldt 350 glaucoma drainage devices.A study was done to compare rates of surgical and clinical success in patients with ahmed fp7 (fp7), baerveldt 250 (b250), or baerveldt 350 (b350) glaucoma drainage devices (gdds).A total of 347 eyes were enrolled in the 2-year study period, divided into gdd groups: (n=157 eyes) with fp7 (n=43 eyes, 12.4%), 36 (b250 (n=36 eyes, 10.4%), 78 (b350 (n=78 eyes, 22.5%); and medically treated eyes (n=190 eyes, 54.8%) as control group.Postoperative complications included: hyphema (b250, n=6; b350, n=11) vitreous hemorrhage (b350, n=2) low endothelial cell density (b350, n=1) corneal edema (b350, n=3) corneal graft failure (b350, n=3) corneal graft decentration (b350, n=1) seidel positivity (b250, n=2; b350, n=3) hypotony (b250, n=2; b350, n=6) choroidal effusion (b250, n=2; b350, n=6) elevated intraocular pressures (b250, n=3; b350, n=11) anterior uveitis (b350, n=3) macular edema (b350, n=2) tube complications were tube occlusion (b250, n=2; b350, n=3) and tube malposition (b350, n=4).Diplopia (b250, n=4; b350, n=9) reasons for failures (b250, n=11; b350, n=32) were: iop = 5 (b250, n=2; b350, n=7); iop > 21 (b250, n=1; b350, n=8); iop reduction <20% baseline (b250, n=7; b350, n=13); additional glaucoma surgery (b250, n=2; b350, n=12); and loss of light perception (b250, n=1; b350, n=1).Interventions to address complications were glaucoma medications and additional glaucoma procedures like gdd (b350, n=7), trabeculectomy (b250, n=1; b350, n=2), trabeculotomy (b350, n=2), and cyclodestruction (b250, n=1; b350, n=1) there were no further interventions reported.A copy of the article is provided with this report.This report captures event for baerveldt 350 (b350).A separate report will be captured for the baerveldt 250 (b250).

Manufacturer Narrative

Section a2: age/date of birth: (n = 76), mean 65.3 (12.3), range (40¿88) section a3: gender n (%): female 37 (47.4) section a4: weight: unknown/not provided section a5: ethnicity: unknown/not provided section a5: race: n (%) , missing 1, african american 0 (0.0), asian 1 (1.3), white 75 (97.4), other 1 (1.3) section b3: date of event: (b)(6) 2022 (the date article was accepted).Section d4: model number: unknown, information not provided.The specific model of the glaucoma implant was not provided.All that was provided in the article was "baerveldt 350" and it is unknown if it was baerveldt glaucoma model bg101-350 or bg102-350.Section d4: catalog number: unknown, as the serial number was not provided.Section d4: serial number: unknown, information not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: udi number: unknown, as the serial number was not provided.Section d6a: if implanted; give date: unknown/not provided.Section d6b: if explanted; give date: n/a (not applicable) there is no indication the device has been explanted.Section h3-other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Section h6: health effect - impact code: 4625 - (sutures, yag, corneal transplant).Citation: kilgore kp, grosinger aj, liu ly, jamali s, arora n, white lj, khanna cl.Comparing surgical and clinical success rates of ahmed fp7, and baerveldt 250 and baerveldt 350 glaucoma drainage devices.J glaucoma.(2023).32(3), pp.210-220.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: upon further review, it was noted that hyphema and vitreous hemorrhage patient codes were not captured in the initial report submitted.Therefore, the information has been captured in this supplemental mdr report and the following fields were updated accordingly: section h6: health effect clinical code: 1911.Section h6: health effect clinical code: 2143.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT
• Type of Device: IMPLANT EYE VALVE
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17244126
• MDR Text Key: 318448956
• Report Number: 3012236936-2023-01582
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-GLAUCOMA SHUNT
• Device Catalogue Number: UNK-GLAUCOMA SHUNT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention