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

Model Number	AR40E
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity: unknown/ not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2021 and (b)(6) 2021.Telephone number: unknown, information not provided.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was unexpected post-op results, with postoperative visual acuity 0.2 after correction.Iol was explanted and replaced with the same model lens of a 1.5 diopter again.After checking the biometric values and confirming that the label of the implanted lens was 4.5d, the operator suspected that there was a difference in the actual power of the lens and proposed.No further information available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Date returned to manufacturer: 05 nov 2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received cut in two parts.Visual inspection under magnification was performed.Results revealed viscoelastic residue on the optic body and haptics.Miq optical inspection was conducted on the returned lens.The result of miq optical inspection was 20.62d instead of the expected 4.5d.The reported complaint was confirmed, and a failure investigation (fi) was initiated.Manufacturing record review: a review of manufacturing records was conducted for the production order finding that serial numbers (b)(6) through (b)(6) were released within specification.No non-conformance (nc) or exception report (er) were found in the record review.The units were released according to specification and in compliance with the product¿s intended use.Optical results of the original production order (po) (b)(4) were reviewed, finding lens serial number (b)(6) power results were 4.47d in accordance with the labeled 4.5d.Additionally, no other complaints have been received for this po, and a one-year historical search was performed for all nc/capas to date.Results revealed no nc/capa related to this complaint.Manufacturing controls require a line clearance to be performed between production orders to ensure there are no material, documents, or components left from the prior production order in the workstation, and there is a limitation of handling one production order at a time.The sequence of production orders processed before and after po (b)(4) was reviewed to rule out a potential mix-up.There were no complaints reported for both pos (before and after).There is no evidence of a product mix-up during the manufacturing process.Although no process deviation was identified, an awareness was conducted to the operators who perform the miq operation as notification of the event.Conclusion: the reported complaint was confirmed, and a failure investigation was completed.A manufacturing record review revealed the device was manufactured and released within specification.Although there was a discrepancy of the lens measurement, there is no evidence of a potential process deviation that could result in a product mix-up during the manufacturing process and no indication of a product malfunction or product quality deficiency.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12523909
• Report Number: 2020664-2021-07503
• Device Sequence Number: 17435552
• Product Code: HQL
• UDI-Device Identifier: 05050474514089
• UDI-Public: (01)05050474514089(17)250620
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 06/20/2025
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2020
• 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: 76 YR
• Patient Sex: Female