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

Model Number AR40M

Device Problem Contamination (1120)

Patient Problems Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown; requested but not provided.The best estimate date is between (b)(6) 2019 and (b)(6) 2022.If explanted, give date: not applicable, as lens the lens remains implanted.(b)(4).Device evaluation: the device was not returned at the manufacturing site, as it remains implanted; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.(b)(4).

Event Description

It was reported by the patient that the patient is experiencing some issues with the -8.0 diopter intraocular lens (iol) that was implanted in the left eye (os).The patient had two retinal detachment (rd) surgeries os on (b)(6) 2017 and (b)(6) 2019 and the patient has severe glaucoma os.Within a year of the (b)(6) 2019 surgery, silicone emulsification bubbles began sticking to the iol.Within two years, emulsification bubbles filled the front half of the left eye's anterior chamber, totally occluding the patient's sight, and preventing doctors from seeing the retina.The doctors are trying to decide to do surgery now or not.Without the variables changing (i.E.The oil or implant composition), the doctors' have determined that the patient will potentially need surgeries every few years.Through follow-up with the patient it was learned that the glaucoma and the rd are pre-existing conditions.The patient is unable to see anything out of the os and is still still unable to see with correction.The patient is unable to perform the following activities: drive, navigate, read books, play sports, enjoy hobbies, draw, paint, garden, cook, cut toe nails, walk outside or in new locations without assistance, grocery shop without assistance, and recognize people.The symptoms had a gradual onset; the patient first noticed the emulsified oil adhering to the iol in aug 2020.Intervention is required, but has not yet been performed.New material and/or procedures may be needed.The intervention is dependent on these efforts and a willing surgeon, as a repeat rd is likely.The patient does not know the exact pre-operative and post-operative visual acuities (va), however estimated uncorrected pre-op va was hand motion and estimated corrected pre-op was 20/100; estimated uncorrected post-op va was hand motion and estimated corrected post-op va on apr 18, 2019 was 20/40.Additional information was received from the patient on dec 07, 2022, which included medical records.The surgeon is looking to perform another surgery soon to replace the emulsified silicone oil os.Medical record 1: date of service (dos) os: (b)(6) 2019 (prior to cataract surgery os) va: os: with correction (cc) hand motion (hm) 2 feet, intraocular pressure (iop) 18 medical record 2: dos: (b)(6) 2019 (after cataract surgery os); patient: 42 (10/26/80), white, female.Complaint: 6 week follow-up - patient (pt) states vision is better in os due to cataract surgery february 2019.Still using durezol every night at bedtime (qhs) left eye only.Having some shooting pain in and around os last 7 days.Seen blue speckles in a grid pattern three times since friday.History of present illness (hpi): ¿left eye, a great deal, 7 days, constantly, pain¿ medical history: rd os, history of trauma (fist) os, degenerative myopia.Eye surgery: yttrium aluminum garnet (yag) capsulotomy os (mar 01, 2019), cataract surgery os (february 2019), pars plana vitrectomy (ppv), laser, silicone oil (so) os ((b)(6) 2017).Eye medications: durezol 0.05% os qhs other medications: none ¿(b)(6) 2022¿ eye review of symptoms (ros) blurred vision, fluctuated vision, distorted vision, eye pain or soreness, general ros normal.Visual acuity: os: without correction (sc) 20/200, pinhole (ph) 20/150, iop 23 external exam: extraocular muscle (eom): normal; confrontation visual field (cvf): full visual field (vf); pupils: no afferent pupillary defect (apd); adnexa: normal; orbit: normal.Anterior segment exam: conjunctiva/sclera: subconjunctiva so bubbles 360, quiet; cornea: clear; anterior chamber: deep and clear; iris: normal; lens: small open posterior capsule (pc), posterior chamber iol (pciol).Fundus exam: cup-to-disc ratio (c/d): 0.8; disc: sharp, pink, flat, peripapillary atrophy (ppa), shallow cup; macula: no heme, retinal pigment epithelium (rpe) mottling and rarefaction; periphery: atrophic scar superior to macula likely from retinotomy, attached with 360 laser; vessels: normal; vitreous: vitrectomized, 90% so fill.Diagnosis test: optical coherence tomography (oct) microphthalmia, anophthalmia, coloboma (mac), both eyes (ou): posterior staphyloma, small inferior rpe atrophy, no fluid or edema, extremely thin choroid.; os: posterior staphyloma, thick so interface vs elevated erm, no srf, virtually no choroid as extremely thin.Problem 1: h33.012, os retinal detachment with single break, left eye.Plan 1: os 1.¿schl¿ ppv, so removal, air-fluid exchange (afx) vs gas os under geographic atrophy (ga).; os 2.Risks, benefits and alternatives (rba) of ppv with so removal discussed including total vision loss, loss of eye, recurrent rd, proliferative vitreoretinopathy (pvr), infection, hemorrhage.Pt understood and wished to proceed.; os 3.Guarded visual prognosis discussed.; os 4.S/p excellent cataract surgery with dr.Mcfarland.; os 5.S/p ppv, laser, 5000 so os may 05, 2017 (mac-off giant retinal tear (grt) rd).Was hm with rd prior to repair, deprivation amplyopia ou based on doctor¿s notes.; os.6.Was to remove so in past, but pt states was self-pay at the time and could not afford to have another surgery to remove.; os 7.Retinal tear (rt)/rd precautions given, call immediately if notes.Problem 2: h44.2e3, ou degenerative myopia with maculopathy, bilateral eye plan 2: ou 1.Monitor.; ou 2.Extreme myopia, posterior staphyloma ou.; ou 3.Myopic foveoschisis os no longer noted on oct.; ou 4.Poor visual prognosis ou.No further information was provided.

• 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: 16045679
• MDR Text Key: 306156243
• Report Number: 3012236936-2022-03186
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2018
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White