VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2025-06874
- Event Type
- Injury
- Date Received
- June 13, 2025
- Date of Event
- June 21, 2024
- Report Date
- June 13, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: EYE (LOND). 2024 OCT;38(15):2912-2919. HTTPS://DOI.ORG/10.1038/S41433-024-03176-0. EPUB 2024 JUN 21. PMID: 38907015; PMCID: PMC11461963.
TITLE: POSTOPERATIVE COMPLICATIONS AND AXIAL LENGTH GROWTH AFTER BILATERAL CONGENITAL CATARACT SURGERY: EYES WITH MICROPHTHALMOS COMPARED TO A COMPARISON GROUP. THE AIM OF THIS STUDY IS TO INVESTIGATE THE POSTOPERATIVE CLINICAL OUTCOMES AND AXIAL LENGTH (AL) GROWTH OF INFANTS WITH CONGENITAL CATARACTS AND MICROPHTHALMOS FOLLOWING FRST-STAGE CATARACT SURGERY. BETWEEN JANUARY 2016 AND OCTOBER 2020, A TOTAL OF 21 INFANTS (42 EYES) IN THE MICROPHTHALMOS GROUP AND 29 INFANTS (58 EYES) IN THE COMPARISON GROUP UNDERWENT LENSECTOMY COMBINED WITH LIMITED ANTERIOR VITRECTOMY WITHOUT PRIMARY IOL IMPLANTATION WHILE USING 10¿0 ABSORBABLE VICRYL SUTURES (ETHICON, SOMERVILLE, NJ, USA). REPORTED COMPLICATIONS ARE: N=11; GLAUCOMA-RELATED ADVERSE EVENTS. TREATMENT: NOT REPORTED. N=20; POSTERIOR SYNECHIAE. TREATMENT: NOT REPORTED. N=9; VISUAL AXIS OPACIFCATION. TREATMENT: NOT REPORTED. IN CONCLUSION, EARLY SURGICAL INTERVENTION IMPROVES VISUAL FUNCTION IN INFANTS WITH CONGENITAL CATARACTS AND MICROPHTHALMOS. AND MICROPHTHALMIC EYES HAD A HIGHER INCIDENCE OF POSTOPERATIVE GLAUCOMA THAN NORMALLY DEVELOPED EYES. AFTER CATARACT REMOVAL, THE AL GROWTH OF MICROPHTHALMIC EYES IS SLOWER THAN THAT OF NORMALLY DEVELOPED EYES, PROVIDING AN IMPORTANT BASIS FOR SURGEONS TO CHOOSE THE TIMING OF SECONDARY IOL IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376041 | VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |