MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_SENSAR; INTRAOCULAR LENS

Model Number UNKNOWN

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

Patient Problems Wound Dehiscence (1154); Macular Edema (1822); Corneal Clouding/Hazing (1878); Vitreous Loss (2142)

Event Type  Injury  

Manufacturer Narrative

Age at surgery (years): 60.40 +/- 9.35 (range, 39¿77).Sex/gender: female / male: 13 (23%) / 43 (77%).Weight & ethnicity: information unknown, not provided.Date of event: exact dates not provided, article acceptance date is december 16, 2020 model number: unknown, information not provided.A complete catalog number is unknown as the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: the udi number is unknown, as the serial number was not provided.Implant date: unknown, information not provided.If explanted, give date: not applicable, as the lens remains implanted.The intraocular lens (iol) is not returning for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.As the serial number of the device is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.(b)(4).Citation: choi, hj., kwon, ow., byeon, sh., song, jh., clinical outcomes of combined pars plana vitrectomy and scleral fixation of the intraocular lens with a suspension bridge method in eyes with aphakia or insufficient capsular support.Acta ophthalmol.(2021),nov;99(7):pp1-7.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: article: clinical outcomes of combined pars plana vitrectomy and scleral fixation of the intraocular lens with a suspension bridge method in eyes with aphakia or insufficient capsular support.This retrospective case series was performed to describe a modified technique of scleral fixation for intraocular lens (iol) implantation and report the clinical outcomes of combined pars plana vitrectomy (ppv) and scleral fixation using the suspension bridge method.The procedure involved the use of sensar ar40 monofocal 3-piece iol (johnson and johnson vision, santa ana, ca, usa).A total of 76 patients (n=77 eyes) underwent combined ppv and scleral fixation with the suspension bridge method during the study period.But only 56 aphakic or phakic and pseudophakic patients (n=57 eyes) who underwent follow-up for at least 3 months were included in the analysis.Twenty patients (n=20 eyes) were excluded due to the short follow-up period and due to corneal opacity, amblyopia and macular degeneration or macular atrophy.Postoperative complications included corneal wound dehiscence in 1 eye (1.8%), vitreous incarceration in 1 eye (1.8%), optic-iris capture in 6 eyes (10.5%), cystoid macular edema (cme) in 1 eye (1.8%), iol tilt in 1 eye (1.8%) and iol dislocation in 1 eye (1.8%) due to suture knot slippage from the superior haptic and the iol was dislocated into the vitreous cavity with the inferior haptic in place.Interventions done were wound closure for wound dehiscence; yttrium aluminium garnet (yag) laser vitreolysis for vitreous incarceration.Optic iris capture was treated by a mydriatic agent with or without laser peripheral iridectomy.Cme was treated with intravitreal bevacizumab injection.The tilted iol was observed without any treatment and the iol dislocation case required reoperation with no serious complications during the follow-up period.This report is for the adverse events mentioned in the article.Separate reports are being submitted for the iol dislocation event due to suture knot slippage and for the reported tilted intraocular lens (iol).

• Brand Name: UNK_SENSAR
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13985205
• MDR Text Key: 293610657
• Report Number: 3012236936-2022-00843
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK-SENSAR_UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• 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