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

Model Number	AR40E
Medical Device Problem Codes	Material Fragmentation (1261); Inaccurate Delivery (2339)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the leading haptic of the intraocular lens (iol) was detached inadvertently when about half of the lens was already inside the patient's right eye.The incision was enlarged.The lens and the detached haptic were removed from the eye.Vitrectomy was performed and sutures were placed.There was a delay of approximately 45 minutes and medication was prescribed.The patient was left aphakic as there was no suitable lens (a 3 piece iol) available during the surgery to be used as the replacement iol.The patient remained aphakic for 7 weeks ((b)(6) 2022 to (b)(6) 2022) and had regular follow-up consultations during this time.Eventually, the patient was implanted with a 3 piece lens of the same power as the original lens.The original lens was discarded.No other information was provided.
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted.Telephone number: (b)(6).The device was not returned for evaluation as the lens was discarded.Therefore, a failure analysis of the complaint device cannot be completed.A review of the photo, device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Health effect - impact code: (b)(4).Health effect - clinical code: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information from the facility was received and revealed following information: section d10: concomitant medical products: emerald cartridge, emeraldt handpiece.Device evaluation: product evaluation was not performed because the product has not been received.Visual inspection of the customer provided photo revealed the complaint lens inside of the lens case and coated in viscoelastic residue.One haptic can also be observed to be detached from the lens and bent.No further issues could be observed with the photo provided.The complaint issue reported could not be confirmed and no product deficiency could be identified.Conclusion: the complaint issue "delivery issue" was not confirmed.The complaint issue "haptic detached" was observed during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• 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: 15419380
• Report Number: 3012236936-2022-02395
• Device Sequence Number: 6554493
• Product Code: HQL
• UDI-Device Identifier: 05050474502055
• UDI-Public: (01)05050474502055(17)260914
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00175
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian