MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A BV175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Hyphema (1911); Insufficient Information (4580)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
One tube for all: 1-year outcomes after transition to paul glaucoma implant at a tertiary centre.The aim of this prospective observational study was to evaluate the intraocular pressure (iop) lowering effect and success rate of paul glaucoma implant (pgi) in refractory glaucoma after changing practice pattern from ahmed and baerveldt tubes to pgi.From january 2022 to october 2023, a total of 49 patients were included in the study.Consists of 38 male and 11 female.With the mean age of 66.5 ± 16.9 and range 13¿85 years.The devices used during the surgery were ethilon 8¿0-9/0 (ethicon),vicryl 7¿0 (ethicon) and prolene 7¿0 (ethicon) ,viscoat (alcon laboratories, texas, usa) was injected in the ac or healon gv pro (johnson & johnson, california, usa) behind the iris in cases with placement in the sulcus.Reported complications ethilon 8¿0-9/0 (ethicon), vicryl 7¿0 (ethicon), prolene 7¿0 (ethicon).Loss of acuity (n=?), treatment: not reported.Cataract progression (n=?) treatment: not reported.Clinical hypotony (n=?) treatment: not reported.Choroidal detachment (n=?) treatment: not reported.Bcva loss (n=?) treatment: not reported.Maculopathy (n=?) treatment: not reported.Ac shallowing (n=?) treatment: not reported.Hyphaema (n=?) treatment: not reported.Corneal decompensation (n=?) treatment: not reported.In conclusions, this study indicates that pgi provides a good iop-lowering effect after 12 months in a population with risk factors for failure for traditional glaucoma surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: acta ophthalmol.2025 jun;103(4):461-468.Doi: 10.1111/aos.17443.Epub 2025 jan 24.Pmid: 39853904; pmcid: pmc12069969.Https://doi.Org/10.1111/aos.17443.

• Brand Name: PRLNE BLU 24IN 7-0 D/A BV175-8 MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23064758
• Report Number: 2210968-2025-10545
• Device Sequence Number: 10044322
• Product Code: GAW
• UDI-Device Identifier: 10705031201903
• UDI-Public: 10705031201903
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: W8702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown