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

Model Number AR40E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Macular Edema (1822); Intraocular Pressure Increased (1937); Vitreous Hemorrhage (2143); Intraocular Pressure Decreased (4468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The following article was received based on a literature review: article: a 1-year prospective comparative study of sutureless flanged intraocular lens fixation and conventional sutured scleral fixation in intraocular lens dislocation.This prospective, comparative cohort study was done to compare surgical outcomes of sutureless flanged intraocular lens (iol) fixation and conventional sutured scleral fixation (sf) for secondary iol implantation in patients with iol dislocation.The study included 53 patients (n=53 eyes) from the sutured sf group and 50 patients (n=50 eyes) from the flanged iol sensar ar40e (abbott medical optics inc.) fixation group.Within 1 postoperative month, early complications were vitreous hemorrhage (n=2), hypotony (n=1) and intraocular pressure (iop) elevation (n=1); and between 1 and 12 months, late complications were iris capture of iol (n=3) and cystoid macular edema (cme) (n=1).There were no further interventions reported.It was also stated that operating time was significantly shorter for the flanged iol fixation group in treating iol dislocation.

Manufacturer Narrative

Age: 63.3 ± 7.0.Sex/gender: male:female: 27:23.Weight & ethnicity: information unknown, not provided.Date of event: exact dates not provided, article acceptance date is (b)(6) 2020.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.Citation: do, jr., park, sj., mukai, r., kim, hk., shin, jp., park, dh., a 1-year prospective comparative study of sutureless flanged intraocular lens fixation and conventional sutured scleral fixation in intraocular lens dislocation, ophthalmologica 2021; 244(1):pp.68¿75.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 13983059
• MDR Text Key: 293522824
• Report Number: 3012236936-2022-00844
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: AR40E
• 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): Other