MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4IN 10-0 D/A CS106-6,CTC-6; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	9090G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Eye Injury (1845); Hemorrhage/Blood Loss/Bleeding (1888); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: retina, the journal of retinal and vitreous diseases, 2017, volume 37, number 4.(b)(4).
Event or Problem Description
It was reported in a journal article with title: a modified iris suture technique for in-the-bag intraocular lens dislocation.The objective of this retrospective study was to describe a modified iris suture technique of displaced, in-the-bag, one- and three-piece posterior chamber intraocular lens (pciols) that minimizes operative complexity and circumvents the need for secondary lens explantation and replacement.A total of 94 eyes were included in the study.The patients¿ mean age was 83.5 years (range: 74¿99 years).All underwent surgery for repositioning of late, posteriorly dislocated, in-the bag pciols using an iris suture fixation technique from april 2009 to november 2015.A single-armed 10-0 polypropylene suture on a cif-4 or ctc-6 needle (ethicon, inc, somerville,nj), and very wide suture loop was used.A wide pass is used to include the haptic.Two cases of vitreous hemorrhage occurred and were both cleared spontaneously.Two patients had cystoid macular edema and were treated with topical medication.Two patients developed malignant glaucoma and needed an iridectomy with anterior chamber reformation.The authors concluded that this simple and safe iris suture technique to repair in-the-bag iol dislocations will offer a valuable tool to the ophthalmologists who increasingly encounter this challenge.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 03/20/2020.Additional information: h-6 patient codes: 1820,1845,1888,3189 - surgical intervention.

• Brand Name: PRLNE BLU 4IN 10-0 D/A CS106-6,CTC-6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9861081
• Report Number: 2210968-2020-02262
• Device Sequence Number: 2611029
• Product Code: GAW
• UDI-Device Identifier: 10705031022645
• UDI-Public: 10705031022645
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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 Model Number: 9090G
• Device Catalogue Number: 9090G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention