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

Model Number AR40

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

Patient Problems Macular Edema (1822); Eye Injury (1845); Vitreous Hemorrhage (2143)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: group 1: 60.24 ± 14.13 and group 2: 55.35 ± 15.77 (years).Sex/gender: group 1: male: 25, female: 17 and group 2: male: 23, female: 20.Weight/ethnicity: unknown/not provided.Date of event: 2/19/2020 (the date article was published).Model number: partially known, as the serial number was not provided, only provided as ar40.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Serial number: unknown, as the serial number was not provided.Expiration date: unknown, as the serial number was not provided.Unique identifier (udi) number: unknown, as the serial number was not provided.If implanted, give date: unknown/not provided.If explanted, give date: n/a (not applicable) there is no indication the device has been explanted.The device was not returned for analysis.The serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.Ucar, f., cetinkaya, s.(2020) flattened flanged intrascleral intraocular lens fixation technique.Int ophthalmol.40(1), pp.1455¿1460.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: flattened flanged intrascleral intraocular lens fixation technique.A study was done to evaluate the visual outcomes of the patients who had undergone sutureless scleral fixated intraocular lens (iol) implantation operation in which a new modified yamane technique called flattened flanged intrascleral intraocular lens fixation technique was applied.A total of 85 eyes of 85 patients were divided into two groups: group 1 consisted of 42 eyes who had undergone scleral iol fixation operation with yamane technique (off-label) while group 2 composed of 43 eyes who had undergone scleral iol fixation operation with flattened flange technique (off-label).All patients were implanted with sensar ar40 3-piece iol (abbott medical optics).Complications reported in group 1 include intraoperative haptic sliding (n=3 eyes), postoperative iol dislocation (n=1 eye), postoperative iris capture (n=2 eyes), vitreous hemorrhage (n=4 eyes), cystoid macular edema (n=2 eyes).Complications reported in group 2 include iris capture (n=1 eye), vitreous hemorrhage (n=2 eyes), and cystoid macular edema (n=1 eye).The iris captures were concluded to be pertaining to the anterior chamber depth and treated with mydriatics.Topical nevanac drops (nepafenac %0.1, alcon) were administered for the treatment of cystoid macular edema.In group 1, the preoperative (endothelial cell density) ecd (cell/mm2) is 2387.06 ± 22.14 (2347¿2421) and the postoperative ecd (cell/mm2) is 2268.33 ± 14.77 (2251¿2289).In group 2, the preoperative (endothelial cell density) ecd (cell/mm2) is 2382.02 ± 17.12 (2355¿2415) and the postoperative ecd (cell/mm2) is 2283.80 ± 10.66.This report is to capture the adverse events in groups 1 and 2.A separate report is being submitted to capture the product problem for this model.

• Brand Name: SENSAR IOL
• 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: 14015851
• MDR Text Key: 294284209
• Report Number: 3012236936-2022-00854
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 04/05/2022

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
• Device Operator: Health Professional
• Device Model Number: AR40
• Device Catalogue Number: AR40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/05/2022
• 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