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

Model Number	GAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Macular Edema (1822)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent cataract surgery in the left eye (os) and a monofocal intraocular lens (iol) was implanted.The ophthalmic viscosurgical device used was from another manufacturer.No surgical complications occurred.On (b)(6) 2021, the patient was examined and presented an intraocular pressure (iop) of 14 mmhg (1 mmhg from the baseline).The uncorrected distance visual acuity (ucdva) was 0.32.The following medical findings were observed: drusen and epiretinal membrane.The patient cup-to-disc ratio was 4 and the patient also presented with retinal pigment epithelium (rpe) changes.On (b)(6) 2022, during the 6th month post-operative visit, the patient presented with an iop of 15 mmhg (2 mmhg from the baseline) and a manifest refraction of 1.0 -0.75 15°.The best corrected distance visual acuity (bcdva) was 0.10 and the patient was diagnosed with cystoid macular edema during the clinical exam.The cup-to-disc ratio was 4.The patient was administered triamcinolone due to irvine gass syndrome.On (b)(6) 2022, during the 12th month pos-operative visit, the patient presented and iop of 19 mmhg (6 mmhg from the baseline).The values of the manifest refraction were 0.5 -0.5 35°.The bcdva was 0.63.Further injections of triamcinolone and ozurdex were planned.Through follow-up, we learned that the patient was temporarily impaired.No further information was provided.
Additional Manufacturer Narrative
Section a4: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6b - explant date: not applicable, lens remains implanted.Section e1 - email address: unknown/not provided.Section e1 - telephone number: (b)(6) device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD
• Common Device Name: 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: 19753654
• Report Number: 3012236936-2024-000198
• Device Sequence Number: 9004915
• Product Code: HQL
• UDI-Device Identifier: 05050474621824
• UDI-Public: (01)05050474621824(17)240917
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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 Expiration Date: 09/17/2024
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White